MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-10-26 for AUTOCLAVABLE OPERATIVE TELESCOPE M3-12A manufactured by Gyrus Acmi, Inc. - Norwalk.
[17373951]
Surgeon was doing an ablation and when removing the device, the pt was burned around the cervix.
Patient Sequence No: 1, Text Type: D, B5
[17635977]
Device was received with no abnormalities noted. Analysis of the device found no problems. Device operates according to manufacturer specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519132-2007-00009 |
| MDR Report Key | 935815 |
| Report Source | 05 |
| Date Received | 2007-10-26 |
| Date of Report | 2007-10-15 |
| Date Facility Aware | 2007-09-26 |
| Date Mfgr Received | 2007-09-26 |
| Date Added to Maude | 2007-11-07 |
| 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 | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042739 |
| Manufacturer G1 | GYRUS ACMI, INC. - NORWALK |
| Manufacturer Street | 93 NORTH PLEASANT STREET |
| Manufacturer City | NORWALK OH 44857040 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44857 0409 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTOCLAVABLE OPERATIVE TELESCOPE |
| Generic Name | NONE |
| Product Code | FBP |
| Date Received | 2007-10-26 |
| Returned To Mfg | 2007-10-09 |
| Model Number | M3-12A |
| Catalog Number | M3-12A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 910338 |
| Manufacturer | GYRUS ACMI, INC. - NORWALK |
| Manufacturer Address | NORWALK OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-10-26 |