FDA Adverse Event Summary report: N

KERRISON 1 MM GOLD TIP RONGEUR

MDR report key: 14680 · Received July 14, 1994

Report

Report Number
MW1002819
Date Received
July 14, 1994
Date of Event
May 7, 1994
Report Date
June 29, 1994
Manufacturer
AESCULAP INSTRUMENTS CORP.
Product Code
HTX
Report Source
Voluntary report
Reporter Location
NJ, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

DURING SURGICAL PROCEDURE TIP WAS DISCOVERED TO BE MISSING OFF RONGEUR. POSSIBLE RETENTION OF MISSING PIECE (NOT FOUND DURING SURGERY). X-RAY SHOWS FOREIGN BODY BUT UNABLE TO DETERMINE WHETHER MISSING PIECE OR SURGICAL CLIP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 KERRISON 1 MM GOLD TIP RONGEUR RONGEUR HTX AESCULAP INSTRUMENTS CORP. FF771

Patients

Seq Age Sex Outcome Treatment
1 70 YR