LAPAROSCOPIC TROCAR SLEEVE 8351.07

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-05 for LAPAROSCOPIC TROCAR SLEEVE 8351.07 manufactured by R Wolf, Gmbh.

Event Text Entries

[6887] During a laparoscopic procedure, a small section of fiberglass material broke off of the tip. The fragment was retrieved from the pt's abdomen. No other problems were reported. The piece was discarded by the user facility. Device labeled for single use. Patient medical status prior to event: unknown. 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. 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1418479-1994-09065
MDR Report Key9386
Date Received1994-08-05
Date of Report1994-07-22
Date of Event1994-07-11
Date Facility Aware1994-07-19
Report Date1994-07-22
Date Reported to FDA1994-07-22
Date Reported to Mfgr1994-07-22
Date Added to Maude1994-12-12
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationUNKNOWN
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameLAPAROSCOPIC TROCAR SLEEVE
Generic NameSAME
Product CodeFBQ
Date Received1994-08-05
Model Number8351.07
Catalog Number8351.07
Lot NumberNONE
ID NumberNA
OperatorOTHER HEALTH CARE PROFESSIONAL
Device Availability*
Implant FlagN
Device Sequence No1
Device Event Key9043
ManufacturerR WOLF, GMBH


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1994-08-05

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