FDA Adverse Event Injury Summary report: N

STORZ CUTTING LOOP

MDR report key: 1100628 · Received August 6, 2008

Report

Report Number
MW5007914
Event Type
Injury
Date Received
August 6, 2008
Date of Event
July 23, 2008
Report Date
August 6, 2008
Manufacturer
KARL STORZ ENDOSCOPY AMERICA INC.
Product Code
FAS
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
LA, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

MD WAS USING 24 FR LOOP. TWO LOOPS BROKE WHILE INSIDE PATIENT'S BLADDER. FIRST PIECE RETRIEVED BY MD. SECOND PIECE WASHED OUT OF BLADDER WITH IRRIGATION. NO PIECES REMAINED IN PT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 STORZ CUTTING LOOP STORZ CUTTING LOOP FAS KARL STORZ ENDOSCOPY AMERICA INC. 34383

Patients

Seq Age Sex Outcome Treatment
1 Disability