MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-11-07 for CLASSIC STAPES PROTHESIS 70142141 manufactured by Gyrus Acmi, Inc..
[2998515]
A series of events in one procedure caused a significant delay in the procedure. Therefore, there was a potential for injury. Surgeon opened one implant and believed it was too short. Surgeon opened a second implant and believed it was also too short. Surgeon opened a third implant and discovered it was the wrong item. Surgeon continued to open implants and was able to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[10321425]
The first two implants described as too short were returned and evaluated and found to meet specification. The third implant described as being the wrong item was confirmed as being mis-packaged. Capa-(b)(4) in process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1037007-2012-00005 |
| MDR Report Key | 2837584 |
| Report Source | 05,06 |
| Date Received | 2012-11-07 |
| Date of Report | 2012-10-08 |
| Date of Event | 2012-10-08 |
| Date Mfgr Received | 2012-10-08 |
| Device Manufacturer Date | 2012-03-01 |
| Date Added to Maude | 2013-02-14 |
| 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 | DOLAN MILLS |
| Manufacturer Street | 2925 APPLING ROAD |
| Manufacturer City | BARTLETT TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal | 38133 |
| Manufacturer Phone | 9013730200 |
| Manufacturer G1 | GYRUS ENT, LLC |
| Manufacturer Street | 2925 APPLING ROAD |
| Manufacturer City | BARTLETT TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38133 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLASSIC STAPES PROTHESIS |
| Generic Name | PARTIAL OSSICULAR REPLACEMENT PROSTHESIS |
| Product Code | ETB |
| Date Received | 2012-11-07 |
| Returned To Mfg | 2012-10-22 |
| Catalog Number | 70142141 |
| Lot Number | MH419407 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | BARTLETT TN 38133 US 38133 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-11-07 |