AUTO SUTURE GIA 90 PREMIUM A)K3G0012D B)030735

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for AUTO SUTURE GIA 90 PREMIUM A)K3G0012D B)030735 manufactured by Us Surgical Corporation.

Event Text Entries

[6825] Patient for bowel surgery-staple gun being used for anastamosis near rectum. Air leak noted after use. Appeared to have fired only halfway. 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. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no 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 Number9277
MDR Report Key9277
Date Received1994-07-29
Date of Report1994-07-11
Report Date1994-07-11
Date Reported to Mfgr1994-03-23
Date Added to Maude1994-12-07
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 NameAUTO SUTURE GIA 90 PREMIUM
Generic NameCOLON STAPLE GUN/SUTURE CARTRIDGE
Product CodeFHM
Date Received1994-07-29
Model NumberA)K3G0012D B)030735
Device Availability*
Implant Flag*
Device Sequence No1
Device Event Key8935
ManufacturerUS SURGICAL CORPORATION


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1994-07-29

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