MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-16 for KOCH STOP AND CHOP MANIPULATOR HOOK 5-1824 manufactured by Oertel Medical Gmbh.
[117572763]
The device has not been returned for investigation. Manufacturing records, including acceptance testing records, were checked for the lot in question, confirming device conformance to specs at time of release. No similar complaints have been received for the device. The user has refused to return the device despite repeated requests to do so. Photographs have been requested from the user as well, but to date nothing has been forthcoming. Therefore, and due to the fact that at least two instruments were in use simultaneously during the procedure, at this time it has not been possible to confirm that the ophthalmic hook subject of this report actually was the instrument that broke. Should additional information and/or the device be received, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[117572764]
The koch chopper's tip allegedly broke off in the patient's eye during the procedure. This was not detected by the doctor until the end of the procedure, when a foreign body (iofb) was seen at the end of case resting on posterior capsule. As per information provided by or staff, the doctor is known for hitting instruments with the phaco tip due to consistently using instruments too close to the phaco tip during procedures. The patient was sent home with the iofb lodged in his eye and told to come back. Ct scan of orbit done (b)(6) 2018 showed an inferior iofb. Viscoelastic material was injected to provide protection for retrieval, but forced the iofb into the angle/equator of the capsular bag. The patient was told to come back 1 month later. By then the iofb was encapsulated in the eye. Intervention by a retinal specialist will be required. No further information is available at this point.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612075-2018-00001 |
| MDR Report Key | 7788785 |
| Date Received | 2018-08-16 |
| Date of Report | 2018-08-16 |
| Date of Event | 2018-05-22 |
| Date Mfgr Received | 2018-07-18 |
| Device Manufacturer Date | 2017-03-08 |
| Date Added to Maude | 2018-08-16 |
| 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 | MS. ANNETTE OERTEL |
| Manufacturer Street | OBERE VORSTADT 19-20 |
| Manufacturer City | TUTTLINGEN, BADEN-WURTTEMBERG 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78532 |
| Manufacturer G1 | OERTEL MEDICAL GMBH |
| Manufacturer Street | OBERE VORSTADT 19-20 |
| Manufacturer City | TUTTLINGEN, BADEN-WURTTEMBERG 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | KOCH STOP AND CHOP MANIPULATOR HOOK |
| Generic Name | OPHTHALMIC HOOK |
| Product Code | HNQ |
| Date Received | 2018-08-16 |
| Catalog Number | 5-1824 |
| Lot Number | 02170367 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OERTEL MEDICAL GMBH |
| Manufacturer Address | OBERE VORSTADT 19-20 TUTTLINGEN, BADEN-WURTTEMBERG 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-16 |