FDA Adverse Event
Malfunction
Summary report: N
NEUROMONITOR BASIC KIT
MDR report key: 15764536
·
Received November 9, 2022
Report
- Report Number
- 3013886523-2022-00546
- Event Type
- Malfunction
- Date Received
- November 9, 2022
- Report Date
- April 7, 2023
- Manufacturer
- INTEGRA LIFESCIENCES SWITZERLAND SAR
- Product Code
- GWM
- UDI-DI
- 10381780520412
- PMA / PMN Number
- K914479
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE MICROSENSOR WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - LOT 5990723 (SN (B)(6)) MET SPECIFICATIONS WHEN RELEASED. FAILURE ANALYSIS - THE ISSUE OF THE COMPLAINT HAS BEEN CONFIRMED: CATHETER CUT INTO 70CM FROM CONNECTOR. THE CATHETER HAS DEEP CRIMPED MARKS WHERE CUT IS. NO TESTING WAS POSSIBLE. THE ROOT CAUSE OF THE ISSUE REPORTED BY CUSTOMER COULD BE DETERMINED AS A MISHANDLING OF THE CATHETER.
Additional Manufacturer Narrative · 0
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
N/A.
Description of Event or Problem · 0
A FACILITY REPORTED THAT DURING A PROCEDURE, THE WHITE WIRE OF THE MICROSENSOR BROKE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2952076 | NEUROMONITOR BASIC KIT | ICP MICROSENSORS | GWM | INTEGRA LIFESCIENCES SWITZERLAND SAR | 826631 | 5990723 | 10381780520412 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |