MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-06-18 for AUTOCLAVABLE FOROBLIQUE TELESCOPE M3-30A manufactured by Gyrus Acmi, Inc..
[18252348]
Gyrus (b)(4) was notified via a summons that an injury occurred during a cystoscopy procedure, our best information leads us to believe the device may be an autoclavable foroblique telescope at this time, but further information may prompt a revision.
Patient Sequence No: 1, Text Type: D, B5
[18409599]
At the time of this report, multiple attempts to obtain further information from the hospital have been unsuccessful, and the device has not yet been returned for evaluation. As a result, a determination cannot be made at this time. If further information becomes available, gyrus (b)(4) will continue the investigation and update the agency accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519132-2013-00015 |
| MDR Report Key | 3184407 |
| Report Source | 00 |
| Date Received | 2013-06-18 |
| Date of Report | 2013-05-22 |
| Date of Event | 2011-05-06 |
| Date Mfgr Received | 2013-05-22 |
| Date Added to Maude | 2013-06-25 |
| 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 | 0 |
| Manufacturer Contact | MR. TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042739 |
| Manufacturer G1 | GYRUS ACMI, INC. |
| Manufacturer Street | 93 NORTH PLEASANT ST. |
| Manufacturer City | NORWALK OH 44857 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44857 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTOCLAVABLE FOROBLIQUE TELESCOPE |
| Generic Name | AUTOCLAVABLE FOROBLIQUE TELESCOPE |
| Product Code | FBP |
| Date Received | 2013-06-18 |
| Model Number | M3-30A |
| Catalog Number | M3-30A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | 93 NORTH PLEASANT ST. NORWALK OH 44857 US 44857 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-06-18 |