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  

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.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.Brand name: hf-resection electrode "plasma-ovalbutton", button, oval, 24 fr., 12°-30°, esg turis.

• 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: 10368833
• MDR Text Key: 201743856
• Report Number: 2951238-2020-00484
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761085516
• UDI-Public: 14042761085516
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2020,08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22766S
• Device Catalogue Number: WA22766S
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/08/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death