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

Model Number	WA22066A
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
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 connection between the handle and the electrode broke and the subject medical device became unusable.As a consequence, the procedure was interrupted to organize a replacement device from another hospital.The intended procedure was then completed successfully, but with a significant delay in procedure time.However, there was no report about an adverse event or patient injury.
Additional Manufacturer Narrative
Additional information: d4 ¿ lot number; h4 ¿ device manufacturer date device evaluation: the suspect medical device was not returned to the manufacturer for investigation/evaluation but to olympus medical systems corporation (omsc), japan (returned to omsc on 2021-06-15).The evaluation at omsc confirmed that an electrode from omsc¿s test equipment could not be inserted into the working element.Also, ¿dirt¿ was observed inside the electrode¿s insertion port.Based on the available information, it is very likely that there was dirt, rust and/or moisture in the teflon body before use, which then resulted in a short circuit.In view of the age of the subject device, the failure was most likely caused by wear and tear due to frequent use in combination with insufficient reprocessing and/or a very large number of reprocessing cycles performed over the years.Thus, the event/incident was 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 working element without showing any abnormalities.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.
Additional Manufacturer Narrative
Additional information: d10 ¿ concomitant medical products and therapy dates device evaluation: the suspect medical device and the hf electrodes specified as concomitant devices were not returned to the manufacturer for investigation/evaluation but to olympus medical systems corporation (omsc), japan (returned to omsc on 2021-06-15).The evaluation at omsc confirmed that an electrode from omsc¿s test equipment could not be inserted into the working element.Also, ¿dirt¿ was observed inside the electrode¿s insertion port.Furthermore, the concomitant hf electrodes provided for investigation showed severe charred stains and melting points at the proximal end.However, the distal ends of the electrodes were not damaged.The described malfunction was not caused by an electrode, but rather, severe evident burns at the proximal end of the electrode indicate insufficient contact between the electrode and the electrode¿s contact in the working element.Thus, based on the available information, it is very likely that there was dirt, rust and/or moisture in the teflon body before use, which then resulted in a short circuit.In view of the age of the subject device, the failure was most likely caused by wear and tear due to frequent use in combination with insufficient reprocessing and/or a very large number of reprocessing cycles performed over the years.Thus, the event/incident was 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 working element without showing any abnormalities.The case will be closed on olympus side with no further actions.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
• Common Device Name: WORKING ELEMENTS (MONOPOLAR, BIPOLAR, FOR KNIVES, FOR PROBES)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 11957469
• Report Number: 9610773-2021-00158
• Device Sequence Number: 17248436
• Product Code: GCP
• UDI-Device Identifier: 04042761051613
• UDI-Public: 04042761051613
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2021

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: WA22066A
• Device Catalogue Number: WA22066A
• Device Lot Number: 152W
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 08/05/2021; 08/19/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 08/09/2021; 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3 OLYMPUS HF-RESECTION ELECTRODES, LOOP, 24 FR.; OLYMPUS SURGMASTER ELECTROSURGICAL UNIT (UES-40S)