FDA Adverse Event Malfunction Summary report: N

ENDO GIA AUTOSUTURE GUN

MDR report key: 6792 · Received July 22, 1993

Report

Report Number: 6792
Event Type: Malfunction
Date Received: July 22, 1993
Date of Event: December 10, 1992
Report Date: January 11, 1993
Manufacturer: US SURGICAL CORP
Product Code: GAG
Product Problem: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

ENDO GIA AUTOSUTURE WAS PLACED ON TISSUE INSIDE PATIENT'S ABDOMEN VIA PORT. INSTRUMENT WAS CHECKED TWICE BY TECH PRIOR TO HANDING TO PHYSICIAN. ENDO GIA GUN WAS FIRED. PHYSICIANS WERE UNABLE TO RELEASE ENDO GIA FROM TISSUE. ANOTHER INSTRUMENT WAS USED TO ASSIST IN THE RELEASE OF THE ENDO GIA. NO FURTHER PROBLEMS.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: A DEVICE FROM SAME LOT WAS EVALUATED. RESULTS OF EVALUATION: NONE OR UNKNOWN, NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDO GIA AUTOSUTURE GUN	AUTOSUTURE GUN	GAG	US SURGICAL CORP	030811	N2L237

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR		Other