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

Model Number WA00014A

Device Problem Break (1069)

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

Event Date 11/14/2022

Event Type  malfunction  

Event Description

Olympus was informed that during a therapeutic hysteroscopic resection procedure, the hf-cable broke and issued an error message on the generator.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 not returned to the manufacturer for evaluation/investigation since it was reportedly discarded.Therefore, the evaluation was performed exclusively on the basis of the available information.Therefore, the cause of the reported event could not be conclusively determined.The reported issue is a known fault pattern which was evaluated as plausible.It is assumed that wear and tear in connection with a repeated tensile/bending load caused single or all wires inside the cable to break.According to the article¿s lot number, the hf cable was manufactured in may 2018.It therefore must be 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, BIPOLAR
• Type of Device: HF-CABLES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): MED CONTACT GMBH; kornbühlstr. 100-102; salmendingen 72393 ; GM 72393
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 16022746
• MDR Text Key: 308555508
• Report Number: 9610773-2022-00709
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• 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: 185W
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• 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
• Patient Sex: Female