MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, BIPOLAR; CABLES/LEADS, ELECTROSURGICAL UNIT

Model Number WA00014A

Device Problem Sparking (2595)

Patient Problem Burn(s) (1757)

Event Date 02/12/2022

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

The customer reports, during a therapeutic turis procedure using a hf-bi-polar cable with a generator, the generator displayed an conductivity error.The user checked the connections and tried again, immediately the cable wa00014a sparked and injured doctors hand trespassing the glove.The cable was replaced and the procedure was finished.There was no adverse effect to the patient reported.The user (physician) experienced a minor burn that did not lacerate the skin on the right hand.The burn was small in size and without gravity (severity).No treatment/intervention was required, the burn was not serious.The doctor did not any require medical attention and continued the day as normal.

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 has been over one (1) year since the subject device was manufactured, therefore, it is found that the cable was used for longer than the specified twelve (12) months.Based on the results of the investigation, it is very likely that the age-related wear in connection with repeated extreme bending or tensile loads most likely led to the breakage of single or all the wires in the cable.This can cause a voltage spike at the damaged area when the generator is activated which may result in a spark and complete disconnection of the plug.The specific cause of the cable sparking was likely due to age-related wear in connection with improper handling.The service life of the cable is limited to twelve (12) months.After this time, the cable should no longer be used.The following information is stated in the instructions for use regarding proper handling of the device: "additionally, the cable must be checked for damage before each use and after reprocessing.By gently pulling on the plug (max.20nm), it can be determined whether the copper strand of the cable is already damaged.If the cable does not give way but remains rigid, the cable is most likely intact.In order not to shorten the service life of the cable any further, the cable should not be wound up with a loop diameter of less than 10cm and when pulling out the cable, the plug should be pulled and not the cable.".Olympus will continue to monitor field performance for this device.

• Brand Name: HF-CABLE, BIPOLAR
• Type of Device: CABLES/LEADS, ELECTROSURGICAL UNIT
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 13738993
• MDR Text Key: 294653885
• Report Number: 9610773-2022-00092
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761076449
• UDI-Public: 04042761076449
• Combination Product (y/n): N
• Reporter Country Code: GT
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

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: WA00014A
• Device Catalogue Number: WA00014A
• Device Lot Number: 20ZW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/11/2022
• Supplement Dates Manufacturer Received: 03/16/2022
• Supplement Dates FDA Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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