MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMA-OVALBUTTON"; RESECTION ELECTRODES WITH HF CABLE

Model Number WA22766S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 07/08/2020

Event Type  Death  

Manufacturer Narrative

Brand name: hf-resection electrode "plasma-ovalbutton", button, oval, 24 fr., 12¿-30¿, esg turis.The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined.If additional information becomes available at a later time, this report will be supplemented.This event has been reported by the importer on mdr# (b)(4).

Event Description

It was reported by the olympus sales representative present during a transurethral resection of the prostate (turp), the patient died on the operating table.It was noted the patient experienced heart rate complications approximately three fourths of the way through the procedure.No allegation of device malfunction has been reported.Although requested, additional information has not been received.

Manufacturer Narrative

This report is being updated to provide the results of the investigation.New information is reported in h6, and h10.Although requested multiple times, no information was given regarding any damage to the electrode or other instruments involved.Based on the available information, no defect or malfunction of the hf-resection electrode was reported.Oste therefore concludes that the olympus hf-resection electrode did not contribute to the reported event.It might have been the case that the issue occurred due to a procedural complication.It not possible to perform a device history record review as the lot number was not provided.A manufacturing and quality control review was performed for the last 24 months of production without showing any non-conformities or deviations regarding the described issue.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on new information obtained from the user facility (see section a2, a3, b5, and e1) and to provide investigation results from the legal manufacturer (section h10).Based on the legal manufacturer's investigation since, no defect or malfunction of the hf-resection electrode was reported.Therefore, concludes that the olympus hf-resection electrode did not contribute to the reported event.No dhr review was performed due to no specific lot number was reported.

Event Description

Based on further communication with the attending physician, the patient's outcome had nothing to do with the subject device.The patient reportedly expired after the procedure and it was reported that the patient's heart suddenly stopped but no autopsy was performed.The exact cause of death remains unknown but the age of the patient cannot be ruled out a contributory factor.

• Brand Name: HF-RESECTION ELECTRODE "PLASMA-OVALBUTTON"
• Type of Device: RESECTION ELECTRODES WITH HF CABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 10374889
• MDR Text Key: 201913080
• Report Number: 9610773-2020-00180
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761085516
• UDI-Public: 14042761085516
• Combination Product (y/n): N
• PMA/PMN Number: K171965
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WA22766S
• Device Catalogue Number: WA22766S
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 92 YR