MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF OVAL BUTTON ELECTRODE; HF-RESECTION ELECTRODE

Model Number WA22566S

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

Patient Problem Death (1802)

Event Date 11/16/2016

Event Type  Injury  

Manufacturer Narrative

Olympus followed up with the user facility to obtain additional information regarding the reported event via telephone and in writing but with no results.The device was not returned to olympus for evaluation.The cause of the patient outcome is unknown.

Event Description

Olympus was informed that a new electrode (button) was used on a patient that previously had urolifts.The electrode (button) was used to carve out their device and to perform a full transurethral resection of the prostate (turp).The procedure lasted about 70 minutes and reported minimal bleeding.There was great visibility throughout the case.Towards the end of the procedure the physician reportedly went to put in catheter but bladder was collapsed.The physician then lifted the blue drape and the patient¿s abdomen was noted to be distended.The physician put in a foley and super pubic catheter.Intervention radiology and ultrasound were called for assistance.The patient was noted to have had several diverticulum, and it was believed that the diverticulum erupted causing fluid to be absorbed.The patient was reportedly taken to intensive care unit (icu) and subsequently expired at night.In addition, the user facility reported that the button electrode was not a contributing factor to the reported event.

• Brand Name: HF OVAL BUTTON ELECTRODE
• Type of Device: HF-RESECTION ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6168590
• MDR Text Key: 62183680
• Report Number: 2951238-2016-00934
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK152092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WA22566S
• Device Catalogue Number: WA22566S
• Device Lot Number: 93203128
• Other Device ID Number: 04042761051590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention