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

Model Number WA00014A

Device Problems Break (1069); Fire (1245); Sparking (2595)

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

Event Date 07/13/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device has not yet been returned to olympus for evaluation/investigation.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 the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

Event Description

Olympus was informed that during a therapeutic transurethral resection of the prostate (turp) procedure, the hf-cable broke, sparked and there was fire.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 the manufacturer for investigation.The investigation confirmed that reported phenomenon which was most likely caused by age-related wear and tear in connection with repeated great bending and/or tensile loads.These caused individual or all wires inside the cable to break.When the generator is activated, this may lead to voltage flashovers in the damaged area, resulting in sparks and the complete severing of one of the connectors on the instrument side.To reduce the risk of occurrence of this fault pattern, the period of use of this cable was limited to 12 months in the ifu.Therefore, this event/incident was attributed to use error.Furthermore, 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 from olympus side with no further actions, but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, 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
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 15110532
• MDR Text Key: 296650070
• Report Number: 9610773-2022-00299
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761076449
• UDI-Public: 04042761076449
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

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: 195W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 07/27/2022
• Supplement Dates Manufacturer Received: 10/27/2022
• Supplement Dates FDA Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2019
• 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
• Treatment: OLYMPUS HF GENERATOR "ESG-400" ((B)(6)).; OLYMPUS OTV-S200 VISERA ELITE II VIDEOSYSTEM.; UNSPECIFIED OLYMPUS RESECTOSCOPE.
• Patient Sex: Male