MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP ¿ MEDIUM, 30°", LOOP, 24 FR., STANDARD; HF-RESECTION ELECTRODES

Model Number	WA47506S
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2022
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 transcervical resection (tcr) procedure the loop wire at the distal end of the resection electrode broke off and fell into the patient.However, no fragments remained inside the patient since they were reportedly retrieved.The intended procedure was completed using another similar device and there was no report about an adverse event or patient injury.
Additional Manufacturer Narrative
Additional information: d4 - lot number; d4 - expiration date; h4 - device manufacturer date; device evaluation: the suspect medical device was not returned to the manufacturer for investigation but to olympus medical systems corporation (omsc), japan (returned to omsc on 2022-08-17).The investigation confirmed that the loop wire at the distal end of the resection electrode had broken off.The cause of this damage and the breakage of the loop wire is most likely usage-related wear and tear.The loop wire at the distal end of the electrode wears out during use and may break, burn or melt.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 resection electrode without showing any abnormalities.The case will be closed from olympus side with no further actions, but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP ¿ MEDIUM, 30°", LOOP, 24 FR., STANDARD
• 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: 15223572
• Report Number: 9610773-2022-00328
• Device Sequence Number: 12373803
• Product Code: JOS
• UDI-Device Identifier: 14042761085042
• UDI-Public: 14042761085042
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161600
• 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): 10/10/2022

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: 09/08/2026
• Device Model Number: WA47506S
• Device Catalogue Number: WA47506S
• Device Lot Number: 1100346041
• Was Device Available for Evaluation?: Yes
• 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: 07/22/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• 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
• Patient Sex: Female