FDA Adverse Event
Malfunction
Summary report: N
5MM, 45CM L-TIP ELECTROSURGICAL PROBE (3BX)
MDR report key: 4163712
·
Received October 10, 2014
Report
- Report Number
- 0002936485-2014-00798
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- September 11, 2014
- Report Date
- September 11, 2014
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- GCJ
- PMA / PMN Number
- K934094
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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 RETURNED AND THE FAILURE MODE WAS CONFIRMED. THE FOLLOWING REPAIR DIAGNOSTIC CODES WERE IDENTIFIED: (1) PITTING ON SURFACE THE FOLLOWING SERVICE CODES WERE IDENTIFIED: (1) REPLACED INSERT THIS DOES CONFIRM THE ALLEGED FAILURE MODE OF INSULATION FAILURE. PROBABLE ROOT CAUSE: POOR AUTOCLAVE RELIABILITY. INCORRECT STERILIZATION/REPROCESSING PROCEDURE. HANDLING PROCEDURES. CONTACT FORCES. PRODUCT USED BEYOND DEFINED USEFUL LIFE. IN SUM, THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULATION HAS BEEN COMPROMISED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULATION HAS BEEN COMPROMISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 644091 | 5MM, 45CM L-TIP ELECTROSURGICAL PROBE (3BX) | LAPAROSCOPE, GENERAL & PLASTIC SURGERY | GCJ | STRYKER ENDOSCOPY-SAN JOSE | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |