FDA Adverse Event
Other
Summary report: N
PILLINGS/WECK
MDR report key: 154246
·
Received March 5, 1998
Report
- Report Number
- MW1013105
- Event Type
- Other
- Date Received
- March 5, 1998
- Date of Event
- February 26, 1998
- Report Date
- March 3, 1998
- Manufacturer
- PILLINGS/WECK
- Product Code
- GDJ
- Report Source
- Voluntary report
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
ON 2/26/98, DURING A SURGICAL PROCEDURE (LEFT KNEE ARTHROSCOPY, HAMSTRING ACL RECONSTRUCTION), AS SURGEON WAS APPLYING PRESSURE WITH KOCHER CLAMP TO GRASP TENDON, A VERY SMALL PIECE OF THE TIP OF KOCHER INSTRUMENT BROKE OFF. THE TIP PIECE WAS IDENTIFIED AND RETAINED. THE INSTRUMENT (INCLUDING TIP PIECE) WAS REMOVED FROM SERVICE. THE PHYSICIAN DETERMINED THERE WERE NO OTHER PIECES AND NO TREATMENT REQUIRED. THE MFR (PILLINGS/WECK) HAS BEEN NOTIFIED, AND A VOLUNTARY FDA REPORT HAS BEEN COMPLETED. THIS IS THE SECOND VOLUNTARY REPORT REGARDING A KOCHER SURGICAL PROCEDURE. PREVIOUS INCIDENT OCCURRED 4/29/98 AND WAS REPORTED TO THE FDA, ECRI AND THE MFR ON MAY 8,1997.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PILLINGS/WECK | KOCHER INSTRUMENT | GDJ | PILLINGS/WECK | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Other |