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

Model Number WA00014A

Device Problems Arcing (2583); Sparking (2595); Explosion (4006)

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

Event Date 02/22/2022

Event Type  malfunction  

Event Description

Olympus was informed that during a therapeutic transurethral resection of the prostate (turp) procedure, the hf-cable exploded when the hf-current was activated.The intended procedure was successfully completed with a similar cable and there was no report about an adverse event or patient injury.

Manufacturer Narrative

The suspect medical device was returned to olympus for evaluation/investigation.However, the evaluation/investigation is still pending since we are waiting for supplemental information from the manufacturer.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, if further information becomes available, this report will be updated.

Manufacturer Narrative

The suspect medical device was returned to olympus for investigation/evaluation.The evaluation/investigation confirmed that the hf-cable is broken near one of the instrument connectors.In the places where the cable has been severed, the stranded copper wires of the cable have melted due to heat influence.This is a known fault pattern.Wear and tear due to frequent use in connection with repeated great bending and/or tensile loads can cause individual or all wires inside the cable to break.When the generator is activated, this can lead to voltage flashovers in the damaged area, which can result in sparking/explosion.According to the article¿s lot number, the hf-cable was manufactured in 2020.It is therefore assumed that it was used longer than the 12 months the cable is designed for.Thus, this event/incident can be attributed to user error.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the hf-cable without showing any abnormalities.The case will be closed on olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: HF-CABLE, BIPOLAR
• Type of Device: HF-CABLES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): MED CONTACT GMBH; kornbühlstr. 100-102; salmendingen 72393
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 13798591
• MDR Text Key: 287406391
• Report Number: 9610773-2022-00102
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761076449
• UDI-Public: 04042761076449
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

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: 203W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/17/2022
• Supplement Dates Manufacturer Received: 03/23/2022
• Supplement Dates FDA Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2020
• 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: OLYMPUS ESG-400 HF-GENERATOR (WB91051W); UNSPECIFIED OLYMPUS RESECTOSCOPE
• Patient Sex: Male