MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, BAND, 24 FR., 30°, STERILE, SINGLE USE, 12 PCS.; HF-RESECTION ELECTRODES

Model Number	A22223C
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2019
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 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 during a therapeutic transurethral resection of the prostate (turp) procedure, the loop electrode¿s cutting performance was perceived as insufficient.As a result, the intended procedure was canceled and will have to be rescheduled.No further information was provided but there was no adverse event or patient injury during the procedure.
Additional Manufacturer Narrative
The suspect medical device was not returned to the manufacturer for evaluation/investigation.Therefore, the manufacturer's evaluation was exclusively performed on the basis of the provided information.According to the available documentation, the end user reports an insufficient power delivered by the 30° hf-resection electrode.It was also reported that an inspection of the electrode was conducted prior to the procedure where no abnormalities were found.Furthermore, a manufacturing and quality control review was performed for the affected lot number of the hf-resection electrode without showing any abnormalities.Therefore, this event/incident was attributed to use error.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 and retrained to correctly use the olympus medical devices.

• Brand Name: HF-RESECTION ELECTRODE, BAND, 24 FR., 30°, STERILE, SINGLE USE, 12 PCS.
• Common Device Name: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 9080334
• Report Number: 9610773-2019-00124
• Device Sequence Number: 14119566
• Product Code: KNS
• UDI-Device Identifier: 14042761029466
• UDI-Public: 14042761029466
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K903323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2023
• Device Model Number: A22223C
• Device Catalogue Number: A22223C
• Device Lot Number: 1000022642
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 10/16/2019
• 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: UNSPECIFIED RESECTOSCOPE; UNSPECIFIED VALLEYLAB GENERATOR
• Outcome Attributed to Adverse Event: Hospitalization