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	Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical devices were not returned to the manufacturer for evaluation/investigation but to an olympus regional repair center (rrc) in australia (returned to rrc on (b)(6) 2023).The evaluation/investigation found three out of four working elements to meet their specification.Only one working element (lot number 114w) was found to be defective in the way that it was difficult to insert the telescope into the working element because the sheath of the working element was deformed.A deformation of the sheath leads to increased friction resistance between the working element and the telescope.The deformation is most likely attributable to wrong handling by the user, more specifically subjecting the device to excessive force.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot numbers 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 during an unspecified resection procedure, a bipolar resection kit was used, and it was reportedly ¿unsatisfactory and inefficient¿.Thus, the intended procedure could not be completed, and a follow-up procedure is required.However, since the hospital was unable to identify the affected product, it sent in four possible working elements: (b)(4) with lot numbers 114w, 166w, 14yw and 20901-0009.No further information was provided.

• 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, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 16458595
• Report Number: 9610773-2023-00614
• Device Sequence Number: 14051778
• Product Code: KNS
• UDI-Device Identifier: 04042761066235
• UDI-Public: 04042761066235
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Type of Report: Initial
• Report Date (Section B): 03/01/2023

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
• Device Lot Number: 114W
• 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: 02/02/2023
• Initial Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2011
• 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
• Patient Sex: Unknown