ENDOPATH DISPOSABLE SURGICAL TROCAR R-0005

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-05 for ENDOPATH DISPOSABLE SURGICAL TROCAR R-0005 manufactured by Ethicon, Inc..

Event Text Entries

[2033] On july 1, 1992, a patient underwent a laparoscopic cholecystectomy. During insertion of the ethicon 5mm disposable trocar the protective sheath did not come down over the trocar and the liver was punctured but otherwise was not significant. The patinet had no complications from this incidentinvalid 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. No imminent hazard to public health claimed. 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: yes. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2732
MDR Report Key2732
Date Received1993-01-05
Date of Report1993-01-01
Date of Event1992-07-01
Date Facility Aware1992-07-01
Report Date1993-01-01
Date Reported to Mfgr1993-01-01
Date Added to Maude1993-03-24
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameENDOPATH DISPOSABLE SURGICAL TROCAR
Generic NameSURGICAL TROCAR
Product CodeFBQ
Date Received1993-01-05
Model NumberR-0005
OperatorOTHER HEALTH CARE PROFESSIONAL
Device Availability*
Implant Flag*
Device Sequence No1
Device Event Key2548
ManufacturerETHICON, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1993-01-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.