MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-ELECTRODE, HOOK, 5 X 330 MM

Model Number A6282

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

The referenced device was not returned to olympus for evaluation.The cause of the reported event could not be determined at this time.Limited information was provided by the user facility as multiple attempts were made to gather more detailed information regarding the reported incident; however no additional information was obtained.However, if additional information becomes available or if the device is returned to olympus for evaluation, this report will be supplemented accordingly.

Event Description

Olympus was informed that during an unspecified therapeutic procedure, the hook of the device broke off.There was no patient injury reported.It was not specified if the hook broke off and fell into the patient; however, the user facility contacted olympus to request information on if the broken hook would be identifiable using an x-ray.

Manufacturer Narrative

This report is being submitted to provide additional information from the original equipment manufacturer (oem) and to update the following sections: the oem conducted a review of the device history records (dhr) for the concerned lot number which showed no deviations or non-conformities for the device during the manufacturing process.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation results a visual inspection on the received condition of the device confirmed the grey housing around the hook at the distal end was cracked and broken off.The broken piece(s) were not returned along with the device.The hook at the distal end was intact with no damage noted.In addition the blue ring at the handle was loose.There no problems with the hf connector at the proximal end side.No functional testing was performed due to the condition of the device.The exact cause of the reported event could not be determined, however, insufficient handling (unintended) of the device cannot be ruled out as a contributing factor.The instruction manual, section 5.1 inspection and testing, provides warning to mitigate the risk of patient injury which states, ¿impact, fall, shock, or similar stress can result in damage of the ceramic insulation at the sheath¿s distal end.Damaged instruments can cause injuries of the patient and/or user.Do not use the instrument if damaged.¿.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the user facility.The user facility further reported that on april 5, 2018 the doctor was performing an endo-chole procedure.The device¿s lot# is 522028.It remains unknown if the device broke off inside the patient.The intended procedure was completed using the same device.The hook was observed to be missing following the procedure, during pre-cleaning.No other equipment was replaced during the procedure.

• Brand Name: HF-ELECTRODE, HOOK, 5 X 330 MM
• Type of Device: HF-ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• MDR Report Key: 7466101
• MDR Text Key: 107224244
• Report Number: 2951238-2018-00282
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: PK923982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: A6282
• Device Catalogue Number: A6282
• Device Lot Number: 522028
• Other Device ID Number: 04042761028868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1