MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE; HYSTEROSCOPE

Model Number	A22205D
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: hf-resection electrode, loop, 24 fr., 0.2 wire, 30°, sterile, single use, 12 pcs.Pma/510k: k790071/ k903323/ k951863/ k954488.Related patient identifiers: patient identifier: (b)(6) addresses event date on (b)(6) 2023 and patient identifier: (b)(6) addresses event on (b)(6) 2023.The device was returned to olympus for evaluation.A visual inspection confirmed that the loop was missing from the forks on the distal; the distal end was observed under a microscope, there is indication of burnt marks as well as melted insulation on the forks; the forks are slightly bent and deformed; the shaft as well as the proximal end have no indications of bends, kinks, or other signs of damages, and the stabilizing tube appears to have no deformities.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
An olympus representative reported, that during a therapeutic procedure for a trans-urethral resection of prostate, the wire on the distal end was frayed.The procedure was completed using a similar device.There were no reports of patient harm associated with this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the cause of the reported issue is due to wear and tear.The instructions for use state: "use only compatible equipment as listed in this section.If other combinations are used, the full responsibility is assumed by the user.Risk of injury.If any damage to the insulation at the electrode¿s distal end becomes visible during use, replace the electrode with an undamaged electrode.Otherwise, there is a risk of injury for the patient and/or user.Risk of death or serious injury.Improper use of hf current can cause endogenous or exogenous burns, and explosions.Thoroughly review the hf current safety information included in the olympus endoscopy system guide." olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE
• Common Device Name: HYSTEROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16505998
• Report Number: 9610773-2023-00686
• Device Sequence Number: 12336650
• Product Code: GCP
• UDI-Device Identifier: 14042761036716
• UDI-Public: 14042761036716
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K954488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2023

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
• Operator of Device: Health Professional
• Device Model Number: A22205D
• Device Catalogue Number: A22205D
• Device Lot Number: 1000098399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown