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

Model Number	WA22351C
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	09/14/2021
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 transurethral resection of the prostate (turp) procedure, when the surgeon increased the settings from 120 to 200 coag and 200 cut, to reduce the bleeding, first the loop at the distal end of the hf resection electrode broke and fell into the patient and then the roller ball at the distal end of an olympus roller electrode also broke and fell into the patient.However, no fragments remained inside the patient since they were reportedly retrieved.The intended procedure was completed using similar devices but there was an extension of the procedure time of approx.45 minutes.
Additional Manufacturer Narrative
The suspect medical device was not returned to the manufacturer for evaluation/investigation since it was reportedly discarded by the user facility.Therefore, the exact cause of the patient¿s outcome and the reported phenomenon could not be conclusively determined and is being judged as unknown.However, based on the customer's description and our experience, the reported damage was most likely caused by use-related wear and tear.A dhr review could not be performed since basic data of article identification (lot number) is missing.Instead, a manufacturing and quality control review was performed for the last 24 months of production.There were no non-conformities or deviations regarding the described issue.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: HF-RESECTION ELECTRODE, ROLLER, 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 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: 12679851
• Report Number: 9610773-2021-00299
• Device Sequence Number: 4160960
• Product Code: FAS
• UDI-Device Identifier: 14042761051719
• UDI-Public: 14042761051719
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K100275
• 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): 01/05/2022

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 Model Number: WA22351C
• Device Catalogue Number: WA22351C
• 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: 10/19/2021
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS ELECTROSURGICAL GENERATOR ESG-400; OLYMPUS HF-RESECTION ELECTRODE, LOOP; OLYMPUS ELECTROSURGICAL GENERATOR ESG-400; OLYMPUS HF-RESECTION ELECTRODE, LOOP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male