MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS INSERT "HICURA", 5 X 330, JOHANN, MONOPOLAR; ELECTROSURGICAL

Model Number	WA69310M
Medical Device Problem Code	Flare or Flash (2942)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to olympus that during a bariatric operation on january 20, 2023, the connection between the jaw and the stem ¿flared¿ and fell into the surgical field.The patient is fine, there are no injuries to internal organs.There was no injury or health damage due to the reported event.
Additional Manufacturer Narrative
The device will not be returned to olympus for an evaluation.The investigation is still in progress; therefore, the root cause of the reported defect cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.Olympus will continue to monitor the field performance of this device.
Additional Manufacturer Narrative
This medwatch is being supplemented with additional information obtained and the manufacturer's final investigation results.The device was not return for an evaluation.The cause for the reported issue is very likely improper handling/excessive force by the user.The jaws are designed to grasp soft tissue.Improper handling (e.G.Grasping hard material, or twisting the item when grasping) might cause a deformation or breakage.A manufacturing and quality control review was performed for the affected serial number without showing any non-conformities or deviations regarding the described issues.Olympus will continue to monitor the field performance of this device.

• Brand Name: JAWS INSERT "HICURA", 5 X 330, JOHANN, MONOPOLAR
• Common Device Name: ELECTROSURGICAL
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16423087
• Report Number: 9610773-2023-00552
• Device Sequence Number: 12192892
• Product Code: GEI
• UDI-Device Identifier: 04042761079143
• UDI-Public: 04042761079143
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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: WA69310M
• Device Catalogue Number: WA69310M
• Device Lot Number: 22209-0011
• Was Device Available for Evaluation?: No
• 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: 01/23/2023
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2022
• 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