MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12, STERILE, SINGLE USE; HF-RESECTION ELECTRODES

Model Number WA22302D

Device Problem Failure to Cut (2587)

Patient Problem No Code Available (3191)

Event Date 08/14/2020

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 an unspecified therapeutic procedure, the cutting performance of multiple hf resection electrodes of two different lot numbers was reported to have been very poor.As a result, the intended procedure could not be completed successfully and a follow-up procedure was performed on (b)(6) 2020.

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for evaluation/investigation since it was reportedly discarded by the user facility.Instead, eleven other electrodes of the same lot number were returned.The evaluation/investigation confirmed that all returned electrodes are in standard condition.Therefore, the cause of the reported event could not be conclusively determined.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, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12, 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: 10493524
• MDR Text Key: 205661640
• Report Number: 9610773-2020-00205
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761051665
• UDI-Public: 14042761051665
• 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
• Report Date: 10/29/2020

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
• Device Operator: Health Professional
• Device Model Number: WA22302D
• Device Catalogue Number: WA22302D
• Device Lot Number: 1000048484
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/04/2020
• Supplement Dates Manufacturer Received: 10/27/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS UES-40 SURGMASTER ELECTROSURGICAL UNIT; OLYMPUS UES-40 SURGMASTER ELECTROSURGICAL UNIT
• Patient Outcome(s): Required Intervention