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

Model Number WA00014A

Device Problems Break (1069); Sparking (2595)

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

Event Date 03/21/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.A supplemental report will be submitted if any additional information is provided by the user facility.

Event Description

The customer reported to the field service engineer, the high frequency bipolar cable that was connected to the generator (esg-400), sparked, then the cable broke, and then sparks hit the back of the user's hand.The issue was found during preparation for use for a therapeutic, holmium laser enucleation of the prostate procedure.There were no reports of patient or user injury.

Event Description

Additional information obtained identifies the procedure was completed.

Manufacturer Narrative

This report is being supplemented to provide additional information based on information received from the customer (identified via b5 and d10), the legal manufacturer's investigation and device evaluation.The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.Age-related wear and tear in connection with repeated great bending and/or tensile loads most likely caused individual or all wires inside the cable to break.When the generator is activated, this may lead to a voltage flashover in the damaged area, which most likely resulted in sparks and the complete detachment of one of the connectors on the side of the instrument in the case at hand.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the following led to the malfunction: the cable may be damaged by strong mechanical stress during use, e.G.If the user kinks the cable, winds it up with a radius that is too small, or pulls on the cable instead of the connector.This may cause individual or all wires inside the cable to break, resulting in the reported fault pattern.This issue is addressed in the instructions for use (ifu): the service life of the cable is limited to 12 months.After this period, the cable should no longer be used.The cable needs to be checked for damage prior to each use and after reprocessing.By slightly pulling on the connector (with a maximum of 20 n), the user can determine if there is pre-existing damage to the stranded copper wire of the cable.If the cable does not yield but remains rigid, the cable is most likely fine at this place.In order not to reduce the service life of the cable further, the cable should not be wound up with a loop diameter of less than 10 cm, and the user should pull on the connector and not on the cable when unplugging the cable.Olympus will continue to monitor the field performance of this device.

• Brand Name: HF-CABLE, BIPOLAR
• Type of Device: ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16900180
• MDR Text Key: 314895165
• Report Number: 9610773-2023-01272
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761076449
• UDI-Public: 04042761076449
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/12/2023

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: 192W-2398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 05/09/2023
• Supplement Dates Manufacturer Received: 05/24/2023
• Supplement Dates FDA Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2019
• 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
• Treatment: ESG-400; SERIAL # OF ESG-400 IS B005267