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

Model Number WA00013A

Device Problems Break (1069); Arcing (2583); Sparking (2595)

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

Event Date 11/25/2021

Event Type  malfunction  

Event 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.

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.

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
• 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: 12877772
• MDR Text Key: 285527106
• Report Number: 9610773-2021-00342
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761030489
• UDI-Public: 04042761030489
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2018
• 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 BIPOLAR RESECTOSCOPE (WA22367A); OLYMPUS SURGMASTER ELECTROSURGICAL UNIT (UES-40S)