MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, 45° NEEDLE, 24-28 FR., 12° AND 30°, STERILE, SINGLE USE; HF-RESECTION ELECTRODES

Model Number	WA22355C
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2018
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 a therapeutic hysteroscopy procedure, the needle tip at the distal end of the hf resection electrode broke off and a fragment fell inside the patient.However, no fragment remained inside the patient since it was reportedly retrieved.No further information was provided but the intended procedure was completed successfully and there was no report about an adverse event or patient injury.
Additional Manufacturer Narrative
Device evaluation: the suspect medical device was returned to the manufacturer for evaluation/investigation.The evaluation/investigation confirmed that the needle tip at the distal end of the hf resection electrode is broken off.Furthermore, the ceramic insulation shows cracks and the insulation tubes show minor signs of thermal damage.The damage was caused by excessive force and can be classified as mechanically induced wear and tear.Therefore, this event/incident was attributed to use error.Furthermore, 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 related to function and safety.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.

• Brand Name: HF-RESECTION ELECTRODE, 45° NEEDLE, 24-28 FR., 12° AND 30°, STERILE, SINGLE USE
• Common Device Name: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 7845908
• Report Number: 9610773-2018-00082
• Device Sequence Number: 1468737
• Product Code: FAS
• UDI-Device Identifier: 14042761030615
• UDI-Public: 14042761030615
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2018

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: 06/01/2020
• Device Model Number: WA22355C
• Device Catalogue Number: WA22355C
• Device Lot Number: 15194P01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 11/26/2018
• 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 UNIT "ESG-400" (WB91051W)
• Patient Age: 29 YR
• Patient Weight: 51