MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH WORKING ELEMENT, ACTIVE, FOR RESECTION IN SALINE; WORKING ELEMENTS (MONOPOLAR, BIPOLAR, FOR KNIVES, FOR PROBES)

Model Number	WA22366A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's outcome 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 during an unspecified procedure the working element stopped working in the middle of surgery.The surgeon tried to change the diathermy machine and swapped the pedals but it still did not worked.The intended procedure was abandoned.No further information was provided.
Additional Manufacturer Narrative
The suspect medical device was not returned to olympus for evaluation/investigation.Therefore, the evaluation was performed exclusively on the basis of the available information.Based on the information available, the exact cause of the patient¿s outcome and the reported phenomenon could not be conclusively determined and is being judged as unknown.However, based on the customer¿s fault description, damage to the electrical interface is assumed.The electrode contact may have been impaired due to rust or dirt, possibly caused as a result of inadequate reprocessing, which led to electric flashover and consequently to a contact fault.Thus, the reported event/incident can most likely be attributed to use error.A dhr review could not be performed since basic data of article identification (lot number) are missing.Instead, a manufacturing and quality control review was performed for the last 24 months of production.There were no non-conformities or deviations regarding the described issue.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: WORKING ELEMENT, ACTIVE, FOR RESECTION IN SALINE
• Common Device Name: WORKING ELEMENTS (MONOPOLAR, BIPOLAR, FOR KNIVES, FOR PROBES)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; 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: 14798033
• Report Number: 9610773-2022-00241
• Device Sequence Number: 14715041
• Product Code: KNS
• UDI-Device Identifier: 04042761066235
• UDI-Public: 04042761066235
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K030194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA22366A
• Device Catalogue Number: WA22366A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED DIATHERMY MACHINE AND PEDALS
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown