MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-12-22 for GOLD-CUT IRIS SCISSORS SP/SP GEB 11.5CM AD 785-11-01 / 101301 manufactured by Geomed Medizin-technik Gmbh & Co. Kg.
[63063222]
The device history record, including acceptance testing results, was reviewed and found to conform to specifications. The device was subject to function testing and found to conform to specifications. The device was subject to microscopic inspection and no fracture of the tip was observed. No failure detected, device intact.
Patient Sequence No: 1, Text Type: N, H10
[63063223]
According to the dealer, the instrument tip was broken during pediatric surgery. X-ray was taken to confirm no broken parts inside the patient. No harm done.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010168-2016-00005 |
| MDR Report Key | 6197786 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-12-22 |
| Date of Report | 2016-12-22 |
| Date Mfgr Received | 2016-11-22 |
| Device Manufacturer Date | 2013-10-29 |
| 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 | 3 |
| Brand Name | GOLD-CUT IRIS SCISSORS SP/SP GEB 11.5CM |
| Generic Name | SURGICAL SCISSORS |
| Product Code | HNF |
| Date Received | 2016-12-22 |
| Returned To Mfg | 2016-11-24 |
| Catalog Number | AD 785-11-01 / 101301 |
| Lot Number | 297 |
| 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 |