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

Model Number WA00014A

Device Problems Material Split, Cut or Torn (4008); Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 12/21/2022

Event Type  malfunction  

Event Description

The olympus (oth) field service engineer (fse) was informed by the biomedical engineer (bme) at the user facility, the doctor reported ¿little shock sensing during case¿.The bme inspected the high frequency bipolar cable and found the insulation of the cable was torn so the cable was changed.Following the procedure, the defective cable was disposed of, and a new replacement cable was ordered.No death or injury and no impact to patient or other has been reported to olympus.

Manufacturer Narrative

The subject cable was disposed by the user facility; therefore, no device will be returned to olympus.The customer has ordered a new replacement cable, also, the olympus fse was requested by the bme for consultation on preventative action.The device history records (dhr) was performed for the affected serial number without showing any non-conformities or deviations regarding the described issues.The legal manufacturer¿s (oste) investigation determined that there is no design, manufacturing, material or processing related cause for the reported event.However, the reported issue is a known fault pattern and can be confirmed.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.In order to reduce the risk of occurrence of this fault pattern, the period of use of this cable is limited to 12 months in the ifu.The lot number shows that the cable was manufactured in february 2019.As a result, the cable is approximately 4 years old.Therefore, it is likely the cable has been used longer than the 12 months it is designed for.As a result, the damage is most likely attributable to age-related wear and tear in connection with improper handling by the user.In general, the end-user is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.Olympus will continue to monitor complaints related to the device and reported phenomenon.

Manufacturer Narrative

This supplemental mdr was submitted to provide additional details to the event description.The olympus field service engineer recommended the biomed at the user facility to monitor the duration of use of the cable by preparing records as instructed in the instruction for use manual.Also, the biomedical engineer will support to inspect equipment before usage.

Event Description

It was not confirmed if the doctor experienced the reported ¿little shock sensing¿.During the transurethral resection using bioplar technology, sparking was observed from the female connection side of the concerned high frequency bipolar cable.There was a 5-minute delay as the device was changed with another similar cable.No additional anesthesia or sedation was required.There was no impact to the doctor or patient.The device was not inspected prior to procedure.

• Brand Name: HF-CABLE, BIPOLAR
• Type of Device: HIGH FREQUENCY BIPOLAR CABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 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: 16390377
• MDR Text Key: 310065244
• Report Number: 9610773-2023-00522
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761076449
• UDI-Public: 04042761076449
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 03/01/2023
• Supplement Dates FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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