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

Model Number A0393

Device Problems Arcing (2583); Material Split, Cut or Torn (4008)

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

Event Date 03/15/2022

Event Type  malfunction  

Event Description

Olympus technical support engineer was informed by the director of nursing at the user facility that the customer¿s high frequency (hf) monopolar cable reportedly ¿exploded¿ during procedure.The hf cable exploded and burnt towards the end where the hf cord that connects to the hf generator unit.The user replaced the damaged hf cord with another of the same model and was able to complete the procedure.No death or injury to the patient or user was reported to olympus.

Manufacturer Narrative

The customer returned the referenced hf cable for evaluation.A visual inspection confirmed the end of the hf cable where the (male) plug is located is damaged and detached/separated from the cable.Exposed burnt/charred internal wires were identified.Also there was some white residue found near the charred wires.There were no signs of damage to the male and or female connectors.Minor deformation/kink was noted on the cable.The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It is evident from the lot number that the cable was manufactured in september of 2019.It can therefore be assumed that the cable was used for longer than the specified 12 months.Based on the results of the investigation, the cause of the reported issue is most likely due to wear and tear in connection with improper handling.The white deposits found can be explained by the fact that the insulation of the cable may have been damaged before the spark occurred which means that liquid may have entered it during reprocessing.The event can be detected/prevented by following the instructions for use which state: - restricted service life: do not use the hf cable after one year of use.- inspect the cable: visually inspect the cable and the plugs for irregularities on the surface.- damaged cable: do not use a cable with brittle or defective insulation.Replace the cable.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-CABLE, MONOPOLAR
• Type of Device: HF-CABLE , MONOPOLAR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 14117155
• MDR Text Key: 289319752
• Report Number: 9610773-2022-00141
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761001656
• UDI-Public: 04042761001656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A0393
• Device Catalogue Number: A0393
• Device Lot Number: 940767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2019
• 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