MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH UNKNOWN; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, MONOPOLAR, SINGLE-USE

Model Number	UNKNOWN
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus received a medwatch report (mw5111906) reporting the following event: during a cystoscopy for a transurethral resection of the prostate, fulguration of bleeding sites and evacuation of clots with the subject device, after resection, the loop was missing from the shaft of the subject device electrode.The loop was not located in the urinary surgical area, in the irrigation fluid or on the sterile field.During the case, 28, 000 mls of fluid was used.The surgeon reported the loop was either flushed out with the copious amounts of irrigation or disintegrated due to the heat during use of the device.The vendor representative confirmed this possible cause.Surgeon was informed the device broke and was either fragmented or deteriorated and not retrievable and was larger than a 10mm needle, an x-ray was required to locate the fragment per facility policy.Due diligence was done to locate the fragmented loop using a camera and monitor at the end of the procedure and the broken device was not identified.In addition the patient had continuous irrigation post-operatively.A post-operative kidney, ureters, bladder (kub) x-ray was performed and the metallic fragment was identified in the bladder.The patient was discharged to home on hospital day 3.A repeat kub will be obtained in one week and if the fragment remains the patient may need another procedure to remove it.No additional information provided.Model/lot/description a22202c, 10000690-46, hf-resection electrode, loop, 26 fr., 0.35 wire, 12°, sterile, single use, 12 pcs.

• Brand Name: UNKNOWN
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, MONOPOLAR, SINGLE-USE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, germany 22045 ; GM 22045
• MDR Report Key: 15650472
• Report Number: 2429304-2022-00098
• Device Sequence Number: 11395557
• Product Code: KNS
• UDI-Device Identifier: 14042761036662
• UDI-Public: 14042761036662
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/21/2022
• Report Date (Section F): 09/22/2022

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: UNKNOWN
• Device Catalogue Number: A22202C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2022
• 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; Other
• Patient Sex: Unknown