FDA Adverse Event
Other
Summary report: N
KARL STORZ
MDR report key: 2896991
·
Received November 22, 2012
Report
- Report Number
- 9610617-2012-00039
- Event Type
- Other
- Date Received
- November 22, 2012
- Date of Event
- October 28, 2010
- Report Date
- November 21, 2012
- Manufacturer
- KARL STORZ GMBH & CO. KG
- Product Code
- EZO
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE LEGAL SUMMONS DID NOT IDENTIFY THE PART NUMBER OF THE INSTRUMENT INVOLVED. IT COULD BE SERIES (B)(4) COLD KNIVES.
Description of Event or Problem · 1
ALLEGEDLY, THE TIP OF THE COLD KNIFE BROKE OFF IN PATIENT DURING A CYSTOSCOPY AND URETHROTOMY PROCEDURE. THE DOCTOR WAS UNABLE TO REMOVE BROKEN PIECE. ON (B)(6) 2010, THE DOCTOR CONDUCTED SURGERY TO REMOVE RETAINED PIECE, BUT WAS UNABLE TO DO SO. PIECE REMAINS IN PATIENT. THIS OCCURRED AT: (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KARL STORZ | COLD KNIFE | EZO | KARL STORZ GMBH & CO. KG | 27068/27069 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |