PROXIMATE RELOADABLE LINEAR CUTTER TLC7S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-01 for PROXIMATE RELOADABLE LINEAR CUTTER TLC7S manufactured by Ethicon Endosurgery Johnson & Johnson.

Event Text Entries

[9902] On 2/24/94, patient underwent small bowel resection with anastomosis. Patient had to return to surgery on 2/26/94 due to complications and it was noted there were no staples around the area of the anastomosis. Stapling device was suspected to be defective, but since it was a disposable device, this cannot be verified.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number18595
MDR Report Key18595
Date Received1994-08-01
Date of Report1994-04-22
Date of Event1994-02-26
Date Added to Maude1994-12-29
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePROXIMATE RELOADABLE LINEAR CUTTER
Generic NameDISPOSABLE STAPLER
Product CodeHBS
Date Received1994-08-01
Model NumberTLC7S
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age*
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key18523
ManufacturerETHICON ENDOSURGERY JOHNSON & JOHNSON
Manufacturer Address4545 CREEK RD. CINCINNATI OH 452422803 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1994-08-01

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