MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-22 for GOLD-CUT IRIS SCISSORS SP/SP GER 11.5CM AD 784-11-01 / 101300 manufactured by Geomed Medizin-technik Gmbh & Co. Kg.
[63489691]
The device history record, including acceptance testing results, was reviewed and found to conform to specifications. The device was subject to microscopic inspection and showed no signs of pre-existing material damage due to stress corrosion cracking, which indicates that the device may have been subject to inappropriate use. It must also be considered that the scissors involved in the event are delicate scissors intended for ophthalmic use, not for ent surgery. However, due to the fact that the device was returned incomplete, i. E. , the broken-off tip is not available for inspection, it has not been possible to conclusively establish the cause of failure.
Patient Sequence No: 1, Text Type: N, H10
[63489692]
According to the dealer, the instrument tip was broken during ent surgery. No broken parts inside the patient. No harm done.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010168-2016-00004 |
| MDR Report Key | 6197783 |
| Date Received | 2016-12-22 |
| Date of Report | 2016-12-22 |
| Date Mfgr Received | 2016-11-22 |
| Device Manufacturer Date | 2013-08-20 |
| Date Added to Maude | 2016-12-22 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | HANNO HAUG |
| Manufacturer Street | LUDWIGSTALER STRASSE 27 |
| Manufacturer City | TUTTLINGEN, BADEN WUERTTEMBERG 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78532 |
| Manufacturer Phone | 746193550 |
| Manufacturer G1 | GEOMED MEDIZIN-TECHNIK GMBH & CO. KG |
| Manufacturer Street | LUDWIGSTALER STRASSE 27 |
| Manufacturer City | TUTTLINGEN, BADEN-WUERTTEMBERG 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GOLD-CUT IRIS SCISSORS SP/SP GER 11.5CM |
| Generic Name | SURGICAL SCISSORS |
| Product Code | HRR |
| Date Received | 2016-12-22 |
| Returned To Mfg | 2016-11-24 |
| Catalog Number | AD 784-11-01 / 101300 |
| Lot Number | 248 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GEOMED MEDIZIN-TECHNIK GMBH & CO. KG |
| Manufacturer Address | LUDWIGSTALER STRASSE 27 TUTTLINGEN, BADEN-WUERTTEMBERG 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-22 |