MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-ELECTRODE, HOOK LONG, 5 X 450 MM

Model Number A6289

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/12/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.Physical evaluation by the field service engineer confirmed a damaged (cracked) insulation at the distal end of the tube and a bent tube.A supplemental report will be submitted if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the high frequency-electrode, had a damaged (cracked) distal end.The issue was found during reprocessing.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, as well as corrections to d9 and h3.Please see updates to d9, h3, h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the damaged insulation at the distal end is due to improper handling by the user during reprocessing.Additionally, it¿s likely the deformation was caused by excessive force by the user.The final root cause of this event was unable to be identified.The following is included in the instructions for use: ¿warning! infection control risk: properly reprocess the product before first and each subsequent use following the instructions in this manual and in the system guide endoscopy.Improper and/or incomplete reprocessing can cause infection of the patient and/or medical personnel.Warning! risk of injury: defective electrodes are dangerous for the patient as well as for the operating surgeon and must not be used.Never attempt to repair defective hf electrodes, always replace them.Warning! risk of injury: 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.¿ olympus will continue to monitor field performance for this device.

• Brand Name: HF-ELECTRODE, HOOK LONG, 5 X 450 MM
• Type of Device: ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17366548
• MDR Text Key: 320291174
• Report Number: 9610773-2023-01929
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761029551
• UDI-Public: 04042761029551
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K923982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A6289
• Device Catalogue Number: A6289
• Device Lot Number: 908752
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 08/01/2023
• Supplement Dates FDA Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1