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 03/16/2022

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 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.There were no signs of damage to the male and or female connectors.Minor deformation/kink was noted on the cable.The legal manufacturer (oste) performed a review of the device history records for the concerned device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The subject cable was manufactured in august 2011 and was sold in october 2018.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The reported malfunction is a known issue.The age-related wear in connection with repeated extreme bending or tensile loads potentially led to the breakage of single or all wires in the cable which can contribute to a voltage spike at the damaged area when the generator is activated, resulting in a spark and complete disconnection of the plug.In general, the customer is required to check the function of all devices used prior to a procedure and a suitable replacement device must be provided during an application.As stated on the ifu (instructions for use manual) and as a preventative measure, the ifu states that the service life of the cable is limited to 12 months.After this time, the cable should no longer be used.Olympus will continue to monitor complaints 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: 14115741
• MDR Text Key: 298773440
• Report Number: 9610773-2022-00137
• 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
• Report Date: 04/14/2022

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: A0393
• Device Catalogue Number: A0393
• Device Lot Number: 831088
• 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
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2018
• 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