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MAUDE MDR 3199

MDR report key
3199
Report number
3199
Event key
0
Event type
3
Date of event
1992-01-27
Date received
1992-07-06
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
1ENDOPATH DISPOSABLE SURGICAL TROCAR W/RADIOLUCENT SLEEVE10/11 TROCARETHICONFBQR1011R1011N/ANN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11992-07-0601. R

Event Narratives#

D

Patient 1

LAPOROSCOPIC CHOLECYSTECTOMY PLANNED. PATIENT HAD MANY ADHESIONS DUE TO PREVIOUS SURGERIES. UPON ENTRY, TROCAR PERFORATED SIGMOID COLON. TREATMENT INCLUDED SURGICAL REPAIR TO THE COLON AND PROPHYLACTIC ANTIBIOTIC COVERAGEDEVICE 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.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN, OTHER. RESULTS OF EVALUATION: INHERENT RISK OF PROCEDURE, PATIENT'S CONDITION - PREDISPOSED EVENT. CONCLUSION: DEVICE DISCARDED - UNABLE TO FOLLOW-UP, THERE WAS NO DEVICE FAILURE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.