MAUDE Adverse Event Report: OERTEL MEDICAL GMBH KOCH STOP AND CHOP MANIPULATOR HOOK; OPHTHALMIC HOOK

Catalog Number 5-1824

Device Problems Fracture (1260); Use of Device Problem (1670)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: KOCH STOP AND CHOP MANIPULATOR HOOK
• Type of Device: OPHTHALMIC HOOK
• Manufacturer (Section D): OERTEL MEDICAL GMBH; obere vorstadt 19-20; tuttlingen, baden-wurttemberg 78532 ; GM 78532
• Manufacturer (Section G): OERTEL MEDICAL GMBH; obere vorstadt 19-20; tuttlingen, baden-wurttemberg 78532 ; GM 78532
• Manufacturer Contact: annette oertel ; obere vorstadt 19-20; tuttlingen, baden-wurttemberg 78532 ; GM 78532
• MDR Report Key: 7788785
• MDR Text Key: 117572763
• Report Number: 9612075-2018-00001
• Device Sequence Number: 1
• Product Code: HNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5-1824
• Device Lot Number: 02170367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 98