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MAUDE MDR 10010

MDR report key
10010
Report number
10010
Event key
0
Event type
3
Date of event
1994-11-18
Date received
1995-01-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MARLOW NU TIPDISPOSABLE CURVED METZ SCISSORS TIPMARLOW CO.JOKUNKNOWN0161**

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11995-01-3101. *

Event Narratives#

D

Patient 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.