MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, BIPOLAR; GENERATORS

Model Number WA00014A

Device Problem Sparking (2595)

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

Event Type  malfunction  

Event Description

It was reported to olympus that a bipolar resector cable created an electrical arc, during prostate procedure, that caused the patient to flinch and the surgeon to move.The patient was informed of the incident and no immediate consequences were reported other than potential lesions, burns (not confirmed).There was no patient injury or adverse event reported to olympus.This medwatch is being submitted to capture the reportable malfunction.The operator's handpiece reference was: (b)(4).

Manufacturer Narrative

The device was not returned to olympus.The result of the investigation determined that this is a known type of failure.In the course of time, one or more wires inside the cable can break due to permanent bending/tensile stress as well as wear and tear.When activating the generator, a voltage flashover at the damaged area might occur.This very likely causes a spark, as reported by the customer.The instructions for use state: the service life of hf cables is restricted to one year.Furthermore, the cable must be inspected before and after each use and reprocessing cycle.This can be done by slightly pulling the plug to identify if wires inside the cable are pre-damaged (a force with 20 n at most shall be used when pulling the plug).When the cable remains rigid and does not bend, this area of the cable is very likely faultless.Additionally, the cable shall be wound up with a diameter of less than 10 cm.When removing the cable, the plug shall be pulled and not the cable.A manufacturing and quality control review was performed for the affected serial number without showing any non-conformities or deviations regarding the described issues.

• Brand Name: HF-CABLE, BIPOLAR
• Type of Device: GENERATORS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16765922
• MDR Text Key: 313568742
• Report Number: 9610773-2023-01072
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761076449
• UDI-Public: 04042761076449
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2023

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
• Device Operator: Health Professional
• Device Model Number: WA00014A
• Device Catalogue Number: WA00014A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2023
• Initial Date FDA Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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