FDA Adverse Event Injury Summary report: N

ETHICON

MDR report key: 7527 · Received February 22, 1994

Report

Report Number: 7527
Event Type: Injury
Date Received: February 22, 1994
Date of Event: August 24, 1993
Report Date: October 1, 1993
Manufacturer: JOHNSON & JOHNSON COMPANY
Product Code: JOK
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

A SURGEON WAS REMOVING LAPAROSCOPIC DISPOSABLE 5MM SCISSORS FROM 5MM BOTTOM TROCAR SLEEVE, A SLIM 1" LONG PIECE OF TEFLON COATING WAS STRIPPED FROM THE SCISSORS AND DROPPED INTO ABDOMEN. LAPAROTOMY WAS THEN DONE, PIECE OF TEFLON WAS REMOVED, ABDOMEN WAS IRRIGATED, AND SYSTEMIC KEFZOL 1GM WAS ADMINISTERED BY CRNA. 5MM TROCAR SLEEVE LAPAROTOMY PERFORMED AND PIECE OF TEFLON RETRIEVED BY SURGEON. PATIENT ADMITTED TO HOSPITAL POST SURGERY.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. 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: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN, NONE OR UNKNOWN, OTHER. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ETHICON	ENDOPATH DISPOSABLE CURVED SCISSOR WITH UNIPOLAR CAUTERY -5M	JOK	JOHNSON & JOHNSON COMPANY	DCS12	EC8766

Patients

Seq	Age	Sex	Outcome	Treatment
1	46 YR		Required Intervention