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
Additional Manufacturer Narrative
The device was not returned for evaluation.The product was repaired onsite at a local service center.A review of the device history record confirmed the device had no non-conformities or deviations regarding the described event.It has been five years since the subject device was manufactured.Based on the results of the investigation, the root cause of the broken cable could not be determined.However, a likely cause is improper handling by the user, in combination with wear and tear.The issue is addressed in the instructions for use (ifu): ¿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 the field performance of this device.
Event or Problem Description
The customer reported that the bipolar cable was broken on an hf-cable, bipolar.The event occurred during preparation for use.There was no patient harm associated with the event.

• 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: 17690633
• Report Number: 9610773-2023-02468
• Device Sequence Number: 6045154
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/06/2023

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: 183W
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2018
• 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