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..
[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
| Report Number | 9680400-2008-00001 |
| MDR Report Key | 1230444 |
| Report Source | 06 |
| Date Received | 2008-11-07 |
| Date of Report | 2008-11-07 |
| Date of Event | 2008-10-10 |
| Date Facility Aware | 2008-10-10 |
| Date Mfgr Received | 2008-10-10 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2009-08-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE RD |
| Manufacturer City | SOUTHBORUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042739 |
| Manufacturer G1 | ACMI CANADA, INC. |
| Manufacturer Street | 5120 HALFORD DR |
| Manufacturer City | WINDSOR, ON N9A-6J3 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | N9A-6J3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SISO II BULLET NOSE DISSECTING FORCEPS |
| Generic Name | SISO II BULLET NOSE DISSECTING FORCEPS |
| Product Code | HCZ |
| Date Received | 2008-11-07 |
| Model Number | LA2-5273 |
| Catalog Number | LA2-5273 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACMI CANADA, INC. |
| Manufacturer Address | WINDSOR, ON CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-11-07 |