MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH WORKING ELEMENT, PASSIVE

Model Number WA22067A

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2019

Event Type  malfunction  

Manufacturer Narrative

The wa22067a was not returned for evaluation.The exact cause of the reported event could not be conclusively determined.Based on similar reported events, the potential cause can be attributed to debris/fluid inside the teflon body which can cause the electrode to not attach securely to the working element which can cause spark discharge upon activation.As a preventive measure, the instruction manual instructs, "before us, to make sure that the product has been properly reprocessed inspected, and tested." the manual also provides warning to mitigate the risk of injury to the patient or user which states, "when attaching the electrode to the working element, make sure that the electrode clicks into position audibly, and check the locking and position of the electrode as described below.If the electrode is not attached securely to the working element, spark discharge may occur and the instrument may be damaged.If the device is returned for evaluation at a later date, this report will be supplemented accordingly.Additionally, the oem conducted a review of the device history records (dhr) for the affected lot and indicated there was no deviations or non-conformities during production.

Event Description

The manufacturer was informed that during the middle of a monopolar transurethral resection of a prostate (turp) procedure, the electrode was not seating correctly in the working element which caused charring at the point where the electrode contact the working element.The electrode can be disconnected from the working element without unlocking it.After switching to a different electrode and experiencing the same problem.The physician switched to bipolar resection equipment and successfully finished the procedure.There was moderate bleeding which was attempted to be controlled by using monopolar coag, but eventually switching to bipolar.The procedure was delayed by ten to fifteen minutes.There was no error messages observed from the generator.There was no patient or user injury reported.

• Brand Name: WORKING ELEMENT, PASSIVE
• Type of Device: WORKING ELEMENT
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8701850
• MDR Text Key: 148175495
• Report Number: 2951238-2019-00941
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761051620
• UDI-Public: 04042761051620
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22067A
• Device Catalogue Number: WA22067A
• Device Lot Number: 161W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1