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

Model Number	WA22367A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/26/2019
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 an unspecified hysteroscopy procedure under general anesthesia, it was noticed that the gap between the scope and the sheath was leaky and the uterine cavity could not be seen.Therefore, the operation was cancelled and a follow-up hysteroscopy procedure had to be scheduled to complete the initially intended procedure.No further information was provided, but the patient's condition is reportedly good after the procedure.
Additional Manufacturer Narrative
Device evaluation: the suspect medical device was not returned to olympus for evaluation/investigation.Therefore, the investigation/evaluation was performed exclusively on the basis of the information provided by the customer.According to the customer, the device was found to be leaking from the gap between the scope and the sheath during a hysteroscopy procedure.Based on the customer's description and our experience, it can be assumed that the leak was most likely caused by a defective element between the outer shaft, the inner shaft and the working element.Since it is clearly stated in the instructions for use that the product has to be visually inspected and tested before use, this event/incident was attributed to use error.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 on olympus side with no further actions.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: WORKING ELEMENT, PASSIVE, 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 22045 ; GM 22045
• MDR Report Key: 8891967
• Report Number: 9610773-2019-00109
• Device Sequence Number: 1617650
• Product Code: KNS
• UDI-Device Identifier: 04042761066242
• UDI-Public: 04042761066242
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2019

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 Model Number: WA22367A
• Device Catalogue Number: WA22367A
• Device Lot Number: 18XW
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention