FDA Adverse Event
Malfunction
Summary report: N
STORZ KELLY MEMBRANE DECEMET PUNCH
MDR report key: 41665
·
Received September 19, 1996
Report
- Report Number
- 1932180-1996-00074
- Event Type
- Malfunction
- Date Received
- September 19, 1996
- Date of Event
- August 14, 1996
- Report Date
- August 20, 1996
- Manufacturer
- STORZ INSTRUMENT CO.
- Product Code
- HNJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
SECTIONS A THROUGH F WERE COMPLETED BY THE MFR. DATE ENTERED IN SECTION F.13 IS THE DATE THE DESCRIPTION OF THE FAILURE WAS RECEIVED. OUTSIDE SHAFT AT TIP HAS SOME MATERIAL BROKEN OFF. TIP OF PUNCH IS BENT. THE MATERIAL MAY HAVE BROKEN OFF WHEN THE HANDLE WAS SQUEEZED WHEN OPERATED. THE CAUSE FOR THE BEND IS NOT KNOWN.
Description of Event or Problem · 1
DURING A CATARACT EXTRACTION PROCEDURE, THIS INSTRUMENT BROKE. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN PIECE FROM THE PATIENT'S EYE. THERE WERE NO PATIENT PROBLEMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STORZ KELLY MEMBRANE DECEMET PUNCH | CORNEO-SCLERAL PUNCH | HNJ | STORZ INSTRUMENT CO. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |