FDA Adverse Event Summary report: N

MARLOW NU TIP

MDR report key: 10010 · Received January 31, 1995

Report

Report Number: 10010
Date Received: January 31, 1995
Date of Event: November 18, 1994
Report Date: January 26, 1995
Manufacturer: MARLOW CO.
Product Code: JOK
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

ON NOVEMBER 18, 1994, DURING LAPAROSCOPIC SURGERY FOR AN ECTOPIC REGNANCY, THE CURVED METZ SCISSORS TIP BROKE OFF IN THE PATIENT AND A LAPAROTOMY WAS REQUIRED TO RETRIEVE THE TIP.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MARLOW NU TIP	DISPOSABLE CURVED METZ SCISSORS TIP	JOK	MARLOW CO.	UNKNOWN	0161

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Invalid Data