MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30, STERILE, SINGLE USE; HF-RESECTION ELECTRODES

Model Number WA22507D

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

Patient Problem Internal Organ Perforation (1987)

Event Date 05/29/2020

Event Type  Injury  

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 Description

Olympus was informed that during a therapeutic transurethral resection in saline (turis) procedure, the patient sustained a perforation of the bladder when the hf resection electrode penetrated the bladder¿s muscle layer.The intended procedure was completed using the same set of equipment and a follow-up procedure was performed to treat the perforation the next day.There was no report about a malfunction of any of the olympus medical devices.

Manufacturer Narrative

Corrected data: d1 - brand name.D4 - model number, catalog number, lot number, expiration date.H4 - device manufacturer date.

Manufacturer Narrative

The suspect medical device was returned to the manufacturer for evaluation/investigation.The hf electrode shows some discoloration due to heat development on a minor section of the loop at the electrode¿s distal end and on the contact part at the electrode¿s proximal end.However, when examined in conjunction with a test working element, the hf electrode met the electrical testing standard.On the basis of the information available, the exact cause of the reported phenomenon and the patient¿s outcome could not be determined and is being judged as unknown.However, based on the event description, the perforation of the bladder was most likely caused by nerve reflexes possibly due to inadequate nerve block anesthesia.Also, the nerve stimulation may have been caused by fluctuations in the current frequency due to a suboptimal contact between the working element and the electrode.Or, the nerve stimulation may have occurred as a result of the surgeon¿s attempt to clean the electrode from adhering deposits within the bladder, which should be done outside the body with bipolar electrodes.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 electrode without showing any abnormalities.The case will be closed from olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30, STERILE, SINGLE USE
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10114023
• MDR Text Key: 193611645
• Report Number: 9610773-2020-00126
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761051689
• UDI-Public: 14042761051689
• Combination Product (y/n): N
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2024
• Device Model Number: WA22507D
• Device Catalogue Number: WA22507D
• Device Lot Number: 1000038533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS HF UNIT "ESG-400"(WB91051J); OLYMPUS HF UNIT "ESG-400"(WB91051J)
• Patient Outcome(s): Hospitalization; Required Intervention