MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMA-OVALBUTTON", OVAL BUTTON, 24 FR., 12°-30°; HF-RESECTION ELECTRODES

Model Number	WA22566S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	12/01/2021
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 patient's outcome 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 vaporization of the prostate in saline (turisv) procedure, the patient's lower abdomen was found to be firm and a change in vital signs was observed.This was suspected to have been caused by an accumulation of saline in the lower abdomen caused by a perforation in the urinary tract that occurred during the turisv procedure allowing saline to enter the peritoneal cavity, which however has not been confirmed so far.The intended procedure was completed using the same set of equipment and there was no report of a malfunction of any of the olympus devices used.
Additional Manufacturer Narrative
The suspect medical device was not returned to the manufacturer for investigation/evaluation since it was reportedly discarded by the user facility.Therefore, the evaluation/investigation was performed exclusively on the basis of the available information.There were no reports of any malfunction of the hf electrode or any of the medical devices used.It is therefore assumed that the hf electrode was in standard at the relevant time.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the hf resection electrode without showing any abnormalities.The case will be closed on olympus side with no further actions.However, the reported phenomenon will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: HF-RESECTION ELECTRODE "PLASMA-OVALBUTTON", OVAL BUTTON, 24 FR., 12°-30°
• Common Device Name: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O.; telickova 457/29; prerov
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 13001091
• Report Number: 9610773-2021-00354
• Device Sequence Number: 5301646
• Product Code: FAS
• UDI-Device Identifier: 14042761083765
• UDI-Public: 14042761083765
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152092
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/12/2024
• Device Model Number: WA22566S
• Device Catalogue Number: WA22566S
• Device Lot Number: 1000053216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLMPUS OUTER SHEATH, 26 FR., 2 STOPCOCKS (A22026A); OLMYPUS INNER SHEATH (A22040T); OLYMPUS HF-CABLE, BIPOLAR (WA00014A); OLYMPUS TELESCOPE "OES ELITE", 4 MM (WA2T430A); OLYMPUS WORKING ELEMENT, PASSIVE (WA22367A); OLYMPUSHF-GENERATOR ESG-400 (WB91051J)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male