FDA Adverse Event
Malfunction
Summary report: N
ETHICON ENDO-SURGERY, INC - REPROCESSED BY STRYKER
MDR report key: 2824721
·
Received November 2, 2012
Report
- Report Number
- MW5027529
- Event Type
- Malfunction
- Date Received
- November 2, 2012
- Date of Event
- October 24, 2012
- Report Date
- November 2, 2012
- Manufacturer
- STRYKER SUSTAINAILITY SOLUTIONS
- Product Code
- LFL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- SC, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING LAPAROSCOPIC CASE, HARMONIC SCALPEL TEFLON TIP FELL OFF. TIP RETRIEVED. SENT TO COMPANY FOR FOLLOW UP. DIAGNOSIS OR REASON FOR USE: LYSIS OF ADHESIONS, R SALPINGOOPHORECTOMY, L PARTIAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHICON ENDO-SURGERY, INC - REPROCESSED BY STRYKER | HARMONIC SCALPEL | LFL | STRYKER SUSTAINAILITY SOLUTIONS | ACE36E | 2150837 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR |