Device product
ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5 *Note: product list updated per 12/23/2020 letter to customers
Z-0497-2021
Product summary
- Event
- Event 86484
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2087
- Official record key
device-enforcement:Z-0497-2021
Official wording
Reason: When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of the ETT, and increased resistance to gas flow and difficulty in ventilating the patient.
Code information: Part/ Lot: 038-990-080U/ 191102901, 200300486, 200300539, 200500068, 200500069, 200803210, 191201567, 200904316, 200904319; 038-990-075U/ 191102900, 200100157, 200300535, 200300536, 200300537, 200402330, 200402331, 200402333, 200402334, 200402335, 200402336, 200402337, 200403976, 200404287, 200500991, 200500992, 200501790; 038-990-070U/ 201000813, 201100558; 038-990-065U/ 201000808, 202002462 *Note: product and lot number list updated per 12/23/2020 letter to customers
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Unknown
When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of the ETT, and increased resistance to gas flow and difficulty in ventilating the patient.