ORIGIN * OMS-T10SB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-07 for ORIGIN * OMS-T10SB manufactured by Origin Medsystems, Inc..

Event Text Entries

[71612] The end of the plastic lock on trocar seal broke off compromising the seal and causing a leak of co2. In order to complete the operative procedure, the laparoscopic birch procedure was converted to an open method procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number112327
MDR Report Key112327
Date Received1997-08-07
Date of Report1997-08-06
Date of Event1997-02-04
Date Facility Aware1997-02-04
Report Date1997-08-06
Date Reported to Mfgr1997-08-07
Date Added to Maude1997-08-14
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 NameORIGIN
Generic NameSTRUCTURAL BALLOON TROCAR & INFLATION BULB 10 MM
Product CodeFCY
Date Received1997-08-07
Returned To Mfg1997-02-04
Model Number*
Catalog NumberOMS-T10SB
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key110276
ManufacturerORIGIN MEDSYSTEMS, INC.
Manufacturer Address135 CONSTITUTION DR. MENLO PARK CA 94028 US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 1997-08-07

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