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

Model Number WA00014A

Device Problems Break (1069); Sparking (2595)

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

Event Date 10/19/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device was returned to the manufacturer for investigation.The investigation confirmed that the hf-cable had broken off from one of the working element connectors and that the wires at the other side of the cable were also broken.In the course of time, one or more wires inside the cable can break due to permanent bending/tensile stress, as well as wear and tear.When activating the generator, a voltage flashover at the damaged area might occur.This very likely causes a spark and the separation of the plug.Since the cable was manufactured in april 2018, the cause for the damage in the case at hand is most likely improper handling in combination with wear and tear as well as end-of life problem.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 bipolar 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.

Event Description

Olympus was informed that during an unspecified plasma procedure, the hf-cable broke, and the physician sustained a small electric shock.No further information was provided but there was no report about an adverse event or patient injury.Reportedly an old cable was used in the procedure at hand.

• 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: 15769641
• MDR Text Key: 307789703
• Report Number: 9610773-2022-00526
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761076449
• UDI-Public: 04042761076449
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 11/10/2022

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: 184W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2022
• Initial Date FDA Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2018
• 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
• Treatment: OLYMPUS HF-GENERATOR "ESG 400" (WB91051W); UNSPECIFIED RESECTOSCOPE