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

Model Number	WA00013A
Medical Device Problem Codes	Break (1069); Arcing (2583); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus was informed that during a therapeutic transurethral resection in saline (turis) procedure, the hf-cable broke and sparked.The intended procedure was successfully completed with a similar cable and there was no report about an adverse event or patient injury.
Additional 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.
Additional Manufacturer Narrative
Correction: d9 - device availability; h4 - device manufacturer date device evaluation: the suspect medical device was not returned to the manufacturer for evaluation/investigation but to olympus medical system corporation (omsc), japan (returned to omsc on 2021/12/05).The evaluation/investigation at omsc confirmed that the hf cable is broken.Age-related wear and tear in connection with a repeated tensile/bending load most likely caused the wires inside the cable to break causing the reported electric sparking when the hf generator was activated.According to the article¿s lot number, the hf cable was manufactured in september 2018.It is assumed that the hf cable was used longer than the 12 months the cable is designed for.Thus, this event/incident can most likely be attributed to age-related wear and tear in connection with improper handling by the customer and thus to use 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
• Common Device Name: 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 ; 4940669662955
• MDR Report Key: 12877772
• Report Number: 9610773-2021-00342
• Device Sequence Number: 4472804
• Product Code: FAS
• UDI-Device Identifier: 04042761030489
• UDI-Public: 04042761030489
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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
• Operator of Device: Health Professional
• Device Model Number: WA00013A
• Device Catalogue Number: WA00013A
• Device Lot Number: 189W
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2021
• Supplement Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 11/26/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS BIPOLAR RESECTOSCOPE (WA22367A); OLYMPUS SURGMASTER ELECTROSURGICAL UNIT (UES-40S)
• Patient Sex: Unknown