MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 30°, STERILE, SINGLE USE; HF-RESECTION ELECTRODES

Model Number	A22205C
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Olympus was informed that during a therapeutic endometrial resection of fibroid procedure, the loop wire at the distal end of the hf resection electrode broke off and fell into the patient.However, no fragment remained inside the patient since it was reportedly retrieved by curettage of the uterus.No further information was provided.
Additional Manufacturer Narrative
Corrected data: d4 - lot number; d4 - expiration date; h4 - device manufacturer date; device evaluation: the suspect medical device was not returned to olympus for evaluation/investigation since it was reportedly discarded by the user facility.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, the reported phenomenon is most likely attributable to wear and tear since the loop wire at the distal end of the hf resection electrode may wear out during use and may break, burn or melt.Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (lot number) are missing.Instead, the manufacturing and quality control review was performed for the last 24 months of production without showing any abnormalities.The case will be closed from olympus side with no further actions.The reported phenomenon will be recorded for trending and surveillance purposes.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 30°, STERILE, SINGLE USE
• Common Device Name: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O.; telickova 457/29; prerov
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 14315832
• Report Number: 9610773-2022-00161
• Device Sequence Number: 20139711
• Product Code: KNS
• UDI-Device Identifier: 14042761036709
• UDI-Public: 14042761036709
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K903323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2024
• Device Model Number: A22205C
• Device Catalogue Number: A22205C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female