SISO II BULLET NOSE DISSECTING FORCEPS LA2-5273

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-11-07 for SISO II BULLET NOSE DISSECTING FORCEPS LA2-5273 manufactured by Acmi Canada, Inc..

Event Text Entries

[995113] During a laparoscopic gynecologic procedure, the blue colored protection piece on the dissecting forceps fell into the pt. The forceps were intact when it was inserted into the body and when it was removed, the blue colored frame piece was missing. The piece was retrieved from the pt, and the pt was fine, released as scheduled and is aware of the incident.
Patient Sequence No: 1, Text Type: D, B5


[8228145] At this time, the device has not been returned to us to complete the investigation. However, according to the info we were able to get from the hospital, the forceps has not been cleaned and sterilized according to the procedure described in the ifu. If further info becomes available or the device is received, gyrus acmi will continue the investigation and update the agency accordingly.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9680400-2008-00001
MDR Report Key1230444
Report Source06
Date Received2008-11-07
Date of Report2008-11-07
Date of Event2008-10-10
Date Facility Aware2008-10-10
Date Mfgr Received2008-10-10
Device Manufacturer Date2006-01-01
Date Added to Maude2009-08-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location3
Manufacturer ContactTERRENCE SULLIVAN
Manufacturer Street136 TURNPIKE RD
Manufacturer CitySOUTHBORUGH MA 01772
Manufacturer CountryUS
Manufacturer Postal01772
Manufacturer Phone5088042739
Manufacturer G1ACMI CANADA, INC.
Manufacturer Street5120 HALFORD DR
Manufacturer CityWINDSOR, ON N9A-6J3
Manufacturer CountryCA
Manufacturer Postal CodeN9A-6J3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSISO II BULLET NOSE DISSECTING FORCEPS
Generic NameSISO II BULLET NOSE DISSECTING FORCEPS
Product CodeHCZ
Date Received2008-11-07
Model NumberLA2-5273
Catalog NumberLA2-5273
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age3 YR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerACMI CANADA, INC.
Manufacturer AddressWINDSOR, ON CA


Patients

Patient NumberTreatmentOutcomeDate
10 2008-11-07

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