MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE; HF-RESECTION ELECTRODE LOOPS AND BANDS

Model Number	WA00013A
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the hf-cable had instructions for use that were possibly incorrect.The event was noticed prior to a therapeutic transurethral resection in saline procedure.There was no patient harm associated with the event.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
This supplemental report is to provide a correction to the initial medwatch report.Initially, this complaint was submitted as a reportable malfunction conservatively.However, upon further review, this is being corrected to a non-reportable event.The initial medwatch reported that the hf-cable had instructions for use that were possibly incorrect; however; per the legal manufacturer, this issue of a typo on the package insert is not likely to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: HF-CABLE
• Common Device Name: HF-RESECTION ELECTRODE LOOPS AND BANDS
• 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: 17930271
• Report Number: 9610773-2023-02908
• Device Sequence Number: 6416559
• Product Code: FAS
• UDI-Device Identifier: 04042761030489
• UDI-Public: 04042761030489
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

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: WA00013A
• Device Lot Number: ¿¿
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown