FDA Adverse Event
Malfunction
Summary report: N
6.5MM CANNULA, 2 ROTATING STOPCOCKS
MDR report key: 3817384
·
Received May 19, 2014
Report
- Report Number
- 0002936485-2014-00329
- Event Type
- Malfunction
- Date Received
- May 19, 2014
- Date of Event
- March 27, 2014
- Report Date
- March 27, 2014
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- NBH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. THE POSSIBLE ROOT CAUSES FOR THE FAILURE CAN BE DUE TO IMPROPER STERILIZATION METHODS AND/OR HANDLING ERROR. HOWEVER, THIS CANNOT BE CONFIRMED SINCE THE UNIT WAS NOT RETURNED. IN THE EVENT THAT THE UNIT IS RETURNED, A FULL EVALUATION WILL BE CONDUCTED AND A FOLLOW UP REPORT WILL BE ISSUED. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION, THUS THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INTERNAL GASKET FELL APART.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INTERNAL GASKET FELL APART.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 297787 | 6.5MM CANNULA, 2 ROTATING STOPCOCKS | ACCESSORIES,ARTHROSCOPIC | NBH | STRYKER ENDOSCOPY-SAN JOSE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |