MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS INSERT "HICURA", 5 X 330, JOHANN, BIPOLAR; HAND INSTRUMENTS, STANDARD, BIPOLAR AND MONOPOLAR

Model Number	WA69410M
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Event or Problem Description
Olympus was informed that after only use in a laparoscopic prostatectomy procedure the jaws insert began to produce an electric arc to the soft tissues in the area of the ceramic insulation.No further information was provided but there was no report about an adverse event or patient injury.
Additional Manufacturer Narrative
The suspect medical device was returned to the manufacturer for investigation.The investigation confirmed the reported damage to the jaws at the device¿s distal end.The ceramic axle was found to be broken and the teflon body was damaged due to burnings.These damages were very likely caused by improper handling.Most likely, an excessive current flashover occurred due to a short circuit, which was caused by either unintended contact with other equipment, or because the distal jaws had permanent contact during high-frequency use without any contact to tissue.Thus, these findings can be attributed to use error.In addition, the proximal end of the jaws was found deformed, which was most likely caused by improper handling (excessive force).The device might have been combined incorrectly and thus excessive force was exerted on the device.Due to this deformation, the overload protection will no longer be triggered correctly.Furthermore, the distal end showed a biofilm which was most likely caused by incorrect reprocessing and can thus also be attributed 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 jaws insert 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.Furthermore, the user will be informed about the investigation results.

• Brand Name: JAWS INSERT "HICURA", 5 X 330, JOHANN, BIPOLAR
• Common Device Name: HAND INSTRUMENTS, STANDARD, BIPOLAR AND MONOPOLAR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 16020466
• Report Number: 9610773-2022-00706
• Device Sequence Number: 6922437
• Product Code: GEI
• UDI-Device Identifier: 04042761079976
• UDI-Public: 04042761079976
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K140624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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: WA69410M
• Device Catalogue Number: WA69410M
• Device Lot Number: 22406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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