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

Model Number WA00014A

Device Problems Break (1069); Circuit Failure (1089); Arcing (2583)

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

Event Date 06/03/2021

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device was returned to the manufacturer for evaluation/investigation.The investigation confirmed that the hf cable is broken.Age-related wear and tear in connection with a repeated tensile/bending load most likely caused single or all 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 june 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.

Event Description

Olympus was informed that during a therapeutic transurethral resection of the prostate (turp) 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.

• Brand Name: HF-CABLE, BIPOLAR
• Type of Device: HF-CABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): MED CONTACT GMBH; kornbühlstr. 100-102; salmedingen 72393 ; GM 72393
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 12596495
• MDR Text Key: 275442636
• Report Number: 9610773-2021-00282
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761076449
• UDI-Public: 04042761076449
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/08/2021

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: 186W-3516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 10/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2018
• 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