MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number WA22302D

Device Problem Material Deformation (2976)

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

Event Date 03/30/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the user noticed damage/deformation to the loop at the distal end of the high-frequency electrode.The issue was found at the start of the therapeutic procedure, when the resectoscope was inserted into the patient.The procedure was completed using a similar device.There were no reports of patient harm.

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.Entire model description in d1: hf-resection electrode,loop.24 fr., 0.2 wire, medium 12° sterile single use, 12 pcs., for turis.

Manufacturer Narrative

This supplemental report is to inform that upon further review, this is not a reportable malfunction.The initial medwatch reported the subject device had damage/deformation to the loop at the distal end of the high-frequency electrode; however; the damage was at the proximal end which is not a reportable malfunction.Per the legal manufacturer, this issue at the proximal end is not likely to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: HF-RESECTION ELECTRODE, LOOP
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg; 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: 16908484
• MDR Text Key: 314980951
• Report Number: 9610773-2023-01279
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761051665
• UDI-Public: 14042761051665
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22302D
• Device Catalogue Number: WA22302D
• Device Lot Number: 1000099486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1