MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS "HIQ+", BIPOLAR, 5 X 330 MM, PREPARATION FORCEPS, MARYLAND, SHORT; BIPOLAR GRASPER

Model Number	WA64320C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus for evaluation, and the customer¿s reported problem was confirmed.The distal end is broken and loose.The lot number of the device could not be confirmed; therefore, a review of the device history records for the concerned device could not be performed.The cause of the reported problem cannot be determined at this time as the investigation is still in progress.However, if additional information becomes available, this report will be supplemented accordingly.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.
Event or Problem Description
Olympus was informed, seven hiq+ bipolar maryland graspers broke while performing total laparoscopic surgeries during the past year.All seven are separate events.It was reported on some of the graspers, sparking was observed on the tip when using with an electrosurgical generator.No device component or fragment fell inside the patient.There was only a 3¿5 minute delay to replace the device as the intended procedures were completed with another like model grasper.The device was inspected before use by the nurse prior to handing the professor.No death or injury and no harm or impact to patient or other was reported to olympus.It was noted the professor at the user facility is known to be one of the most experienced users with the hiq+ bipolar maryland grasper.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Additionally, the manufacturing date cannot be determined as the serial number is unknown.Based on the results of the investigation, the root cause could not be determined.In relation to the broken distal end, the ceramic axle was missing, the teflon body was damaged by burns, and the overload protection was triggered.It is likely these events occurred due to improper handling.The ceramic axle missing was likely caused by previous damage to the axle.The burns at the teflon body indicate that the damage to the axle was most likely caused by a massive high-frequency current flashover.This may be triggered by unintentional contact with other equipment or by permanent contact between the distal jaws without tissue contact during a high-frequency application, which leads to a short circuit inside the device.This short circuit can cause the ceramic axle to break and, as a result, to come loose and fall out.Additionally, the overload protection mechanism at the proximal end of the pull wire was torn/properly triggered due to the severe overload in order to prevent axle breakage or similar damage in the jaw area.Jaw inserts whose overload protection mechanism have been triggered are no longer in standard working condition and should no longer be used.This medwatch, patient identifier (b)(6), is one of seven total reports.For additional reports please see related medwatch with the following patient identifiers: (b)(6).Olympus will continue to monitor field performance for this device.

• Brand Name: JAWS "HIQ+", BIPOLAR, 5 X 330 MM, PREPARATION FORCEPS, MARYLAND, SHORT
• Common Device Name: BIPOLAR GRASPER
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16641132
• Report Number: 9610773-2023-00909
• Device Sequence Number: 6156454
• Product Code: GEI
• UDI-Device Identifier: 04042761062442
• UDI-Public: 04042761062442
• Combination Product (Y/N): N
• Initial Reporter Country: CE
• PMA/510(K) Number: K984417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

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: WA64320C
• Device Catalogue Number: WA64320C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2023
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female