MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, BIPOLAR; BIPOLAR GRASPING FORCEPS BIQ+

Model Number	A60000C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A third-party distributor reported to olympus the cable is broken on hf-cable, bipolar.The therapeutic laparoscopic hysterectomy was completed with a similar device.There were no reports of patient or user harm associated with this event.
Additional Manufacturer Narrative
The subject device was not returned to an olympus service center for evaluation.The issue reported by the customer is plausible.According to the event description, the cable is broken.This is a known fault pattern.Overtime one or more cables can break due to permanent/tensile stress, as well as wear and tear.When activating the generator, a voltage flashover at the damaged area might occur.The cause for this damage is most likely improper handling, in combination with wear and tear.A review of the device history record found no deviations that could have caused or contributed to the reported issue.To avoid this failure, oste recommends following the instructions in the ifu, instructions for use, which states that the service life of hf cables is restricted to one year.Furthermore, the cable must be inspected before and after each use and reprocessing cycle.This can be done by slightly pulling the plug to identify if wires inside the cable are pre-damaged (a force with 20 n at most shall be used when pulling the plug).When the cable remains rigid and does not bend, this area of the cable is very likely faultless.Additionally, the cable shall be wound up with a diameter of less than 10 cm.When removing the cable, the plug shall be pulled and not the cable.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-CABLE, BIPOLAR
• Common Device Name: BIPOLAR GRASPING FORCEPS BIQ+
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17438242
• Report Number: 9610773-2023-02088
• Device Sequence Number: 6834830
• Product Code: GEI
• UDI-Device Identifier: 04042761045285
• UDI-Public: 04042761045285
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K984417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/01/2023

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: A60000C
• Device Lot Number: 21917
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2021
• 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
• Patient Sex: Unknown