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
Medical Device Problem Codes	Break (1069); Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the user's experience 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 or Problem Description
Olympus was informed that during an unspecified therapeutic resection procedure, the distal end of the hf resection electrode broke.It is unknown whether the electrode just broke or whether a fragment broke off and possibly fell into the patient.No further information was provided but there was no report about an adverse event or patient injury.
Additional Manufacturer Narrative
The suspect medical device was returned to the manufacturer for evaluation/investigation.The investigation confirmed that the loop wire and the insulated area of the fork tubes at the distal end of the hf resection electrode show distinct signs of thermal damage.This type of damage is typical for an unintended contact with other metal parts, e.G.Surgical instruments.Also, 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.Therefore, this event/incident was attributed to use error.The case will be closed on olympus side with no further actions.However, the reported phenomenon will be recorded for trending and surveillance purposes.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°, STERILE, SINGLE USE
• Common Device Name: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 8394083
• Report Number: 9610773-2019-00052
• Device Sequence Number: 1341229
• Product Code: FAS
• UDI-Device Identifier: 14042761080177
• UDI-Public: 14042761080177
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2023
• Device Model Number: WA22302D
• Device Catalogue Number: WA22302D
• Device Lot Number: 1000031640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS HF CABLE, BIPOLAR, 4 M (WA00014A); OLYMPUS HF-CABLE, 4 M (WA00013A); OLYMPUS WORKING ELEMENT, ACTIVE (WA22366A); OLYMPUS HF CABLE, BIPOLAR, 4 M (WA00014A); OLYMPUS HF-CABLE, 4 M (WA00013A); OLYMPUS WORKING ELEMENT, ACTIVE (WA22366A)