MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF RESECTION ELECTRODE, NEEDLE, FOR A37014A, STERILE, FOR SINGLE USE; HF-RESECTION ELECTRODES

Model Number	A37012A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus was informed that during a therapeutic transurethral ureteral stenosis dilation procedure, the hf electrode did not come out sufficiently from the sheath when the working element was operated and thus no electricity was applied.Since no spare electrodes had been prepared the intended surgery had to be aborted.No further information was provided.
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Additional Manufacturer Narrative
Device evaluation: the suspect medical device was returned to the manufacturer for evaluation/investigation.The investigation found the wire at the proximal end of the electrode to be bent in two areas and the electrode contact including the wire to be missing.The distal end of the electrode was found to be intact.Due to the dimensional deviation/deformation, the electrode no longer fits into the sheath.This type of damage is caused by improper handling during instrument preparation.Most likely, the electrode was not carefully and securely inserted into the working element as described in the instructions for use but handled with excessive force.Thus, the event/incident can be attributed to user error.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the hf resection electrode without showing any abnormalities.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: HF RESECTION ELECTRODE, NEEDLE, FOR A37014A, STERILE, FOR SINGLE USE
• Common Device Name: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 14573055
• Report Number: 9610773-2022-00201
• Device Sequence Number: 17679028
• Product Code: GCP
• UDI-Device Identifier: 04042761023177
• UDI-Public: 04042761023177
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/26/2025
• Device Model Number: A37012A
• Device Catalogue Number: A37012A
• Device Lot Number: 21101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS SHEATH, 10 FR, FOR RESECTOSCOPE (A37004A); OLYMPUS WORKING ELEMENT (A37014A)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown