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

Model Number WA00013A

Device Problem Labelling, Instructions for Use or Training Problem (1318)

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

Event Date 09/22/2023

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 325603849
• Report Number: 9610773-2023-02908
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761030489
• UDI-Public: 04042761030489
• 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,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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