MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2009-06-04 for SCHRODER HAKENZANGE 25CM GK 620-25-01 manufactured by Geomed Medizin-technik Gmbh & Co. Kg.
[1163808]
The customer reports that the original product was a pilling # ((b)(4)). When cross-referenced to use your product, we ordered a jarit 505-200. Since then, the gyn clinic has had pt's returning due to bleeding for cauterization of the puncture sites. The dr's looked closely and found that this replacement is not the same as the pilling product. It is more rounded at the tip. Not a correct cross-reference the device has been in use by the customer since (b)(6) 2008 through (b)(6), 2009.
Patient Sequence No: 1, Text Type: D, B5
[8436640]
Please refer to manufacturer's complaint investigation report. Additional information from importer report: schroeder tenaculum fcps 10. Catalog# 505200. (b)(4). The device involved in the reported incident has been received for evaluation. An investigation has been initiated based on the reported information. Conclusion: the manufacturer finds absolutely no evidence and has no explanation for how the schroeder tenaculum forceps might have caused the bleeding other than improper use and handling of the device. We also fail to see the connection with regards to the cauterization procedure. Furthermore, the exterior rounded instrument tips are designed to make it a safer device. The five (5) returned instruments meet all quality and functional specifications. In view of the statistics, i. E. A return of 0. 2% of all instruments sold, we cannot detect a problem that might call for corrective or preventive action (please see below representative photographs of the returned devices).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010168-2009-00001 |
| MDR Report Key | 1408779 |
| Report Source | 05,08 |
| Date Received | 2009-06-04 |
| Date of Report | 2009-05-05 |
| Date Facility Aware | 2009-04-06 |
| Date Mfgr Received | 2009-05-20 |
| Device Manufacturer Date | 2007-01-18 |
| Date Added to Maude | 2011-03-25 |
| 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 Street | LUDWIGSTALER STRASSE 27 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78532 |
| Manufacturer Phone | 46193550 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCHRODER HAKENZANGE 25CM |
| Generic Name | FORCEPS GYNAECOLOGICAL |
| Product Code | HCZ |
| Date Received | 2009-06-04 |
| Returned To Mfg | 2009-05-20 |
| Model Number | GK 620-25-01 |
| Catalog Number | GK 620-25-01 |
| Lot Number | 53 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-06-04 |