KARL STARZ ENDOSCOPY - AMERCUE INC 26176FB *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-02-12 for KARL STARZ ENDOSCOPY - AMERCUE INC 26176FB * manufactured by Karl Storz Gmbh & Co. Kg.

Event Text Entries

[309802] Bilateral electrocautery fulguration of both tubes (laparo-scopic tubal ligation). The next day experiencing abdominal pain, required additional surgery exploratory laparatomy - small bowel resection related to bowel injury, likely burn injury. Nine days later additional surgery, small bowel resection due to bowel injury (perforation x2).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	511838
MDR Report Key	511838
Date Received	2004-02-12
Date of Report	2004-02-06
Date of Event	2003-10-17
Date Facility Aware	2003-10-18
Report Date	2004-02-10
Date Reported to FDA	2004-02-10
Date Reported to Mfgr	2004-02-10
Date Added to Maude	2004-02-19
Event Key	0
Report Source Code	User Facility report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
Reporter Occupation	RISK MANAGER
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	KARL STARZ ENDOSCOPY - AMERCUE INC
Generic Name	INSULATED BIPOLAR FORCEP
Product Code	HCZ
Date Received	2004-02-12
Returned To Mfg	2004-02-02
Model Number	26176FB
Catalog Number	*
Lot Number	DY
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	R
Device Age	*
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	500828
Manufacturer	KARL STORZ GMBH & CO. KG
Manufacturer Address	MITTLESTRASSE 8 POSTFACH 230 TUTTLINGEN GM 78503

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other	2004-02-12