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

Model Number	WA22067A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device was not returned to the manufacturer for evaluation/investigation.Therefore, the manufacturer's evaluation was exclusively performed based on the provided information.According to the available documentation, the provision of an incorrectly ordered loaner device led to an extended procedure time during which the patient's lower part of the body was under anesthesia.A product-related malfunction or defect of the olympus medical device was not reported.Furthermore, 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 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.
Event or Problem Description
Olympus was informed that at the beginning of a therapeutic anterior gland resection of the urethra procedure, it was noticed that an incorrect device had been ordered as a loaner device due to which the scheduled procedure had to be switched from a bipolar resection procedure (turis) to a monopolar resection procedure (turp).This resulted in the procedure being extended by 150 to 180 minutes.However, the procedure was successfully completed with the same set of equipment and there was no report about any patient injury.

• Brand Name: WORKING ELEMENT, PASSIVE
• 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: 11045863
• Report Number: 9610773-2020-00296
• Device Sequence Number: 1307900
• Product Code: GCP
• UDI-Device Identifier: 04042761051620
• UDI-Public: 04042761051620
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/21/2020

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 Model Number: WA22067A
• Device Catalogue Number: WA22067A
• Device Lot Number: 068W
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1