26-1221

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-22 for 26-1221 manufactured by Codman & Shurtleff Inc.

Event Text Entries

[18473700] Perforator was checked by the scrub nurse and by the surgeon, prior to use on the patient. The skull perforator was then used on the patient and failed to stop cutting, penetrating the dura. The rea was repaired with sutures. No further complications. Device labeled for single use. Patient medical status prior to event: critical 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. Device was evaluated after the event. Method of evaluation: a device from same lot was evaluated, mechanical tests performed. Results of evaluation: component failure, telemetry failure. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device discarded. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8883
MDR Report Key8883
Date Received1993-07-22
Date of Report1993-01-06
Date of Event1992-12-22
Date Facility Aware1992-12-22
Report Date1993-01-06
Date Reported to FDA1993-01-06
Date Reported to Mfgr1993-01-06
Date Added to Maude1994-10-25
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

Generic NameDISPOSABLE 14MM PERFORATOR WITH HUDSON END
Product CodeHGE
Date Received1993-07-22
Catalog Number26-1221
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityN
Implant FlagN
Device Sequence No1
Device Event Key8544
ManufacturerCODMAN & SHURTLEFF INC


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1993-07-22

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