FDA Adverse Event Injury Summary report: N

SNOWDEN-PENCER, INC.

MDR report key: 147805 · Received January 9, 1998

Report

Report Number
147805
Event Type
Injury
Date Received
January 9, 1998
Date of Event
August 13, 1997
Report Date
September 29, 1997
Manufacturer
SNOWDEN-PENCER
Product Code
GCJ
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
NC, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

PT UNDERGOING A LAPAROSCOPIC CHOLECYSTECTOMY, A SMALL PIECE OF LAPAROSCOPIC GRASPER BROKE IN THE PT. X-RAY PERFORMED AND THE GRASPER TIP WAS LOCATED AND REMOVED FROM THE PT. PT RECOVERED WELL WITH NO COMPLICATIONS. THE RETRIEVED TIP WAS ACCIDENTALLY DISCHARGED. THE INCIDENT ADDED APPROX ONE AND A HALF HRS TO THE PROCEDURE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SNOWDEN-PENCER, INC. LAPAROSCOPIC GRASPER GCJ SNOWDEN-PENCER 90-3005 NA

Patients

Seq Age Sex Outcome Treatment
1 * Required Intervention