MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12/16, PK TURIS

Model Number	WA22603S
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device has been returned to date; therefore, the root cause of the reported malfunction cannot be determined at this time.However, the investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The nurse at the user facility reported, during a cystoscopy transurethral resection of a bladder tumor, the high frequency resection electrode "plasma loop" reportedly broke off inside of a patient's bladder; the surgeon retrieved the broken piece.No death, serious injury or adverse outcome to the patient was reported.
Additional Manufacturer Narrative
The subject device was returned for evaluation.A visual inspection was performed on the device and observed the device was returned opened and used in it's original packaging.The device was wrapped with a plastic wrap on the distal end near the forks and inside the plastic wrap contained the loop, however, the loop was not intact with the electrode.Also, there is a section of the shaft towards the proximal end that is severely bent and deformed.The distal end was observed to have foreign residue near the forks with charred foreign residue on the loop.The loop was returned in one piece and it appears there are no missing portions from the loop; unable to perform any functional tests due to the device being damaged.The legal manufacturer performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The cause of the reported issues is attributed to user error, excessive force as well as improper handling.As stated on the ifu (instruction for use) and as a preventive measure, the user manual indicates: if signs of wear become visible during the procedure, replace the product.Using damaged equipment, equipment that does not function properly or equipment with illegible or missing markings can lead to injury of the patient.Never try to bend the distal tip of the hf-resection electrode.The legal manufacturer will continue to monitor the field performance of this device.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12/16, PK TURIS
• Common Device Name: HF-RESECTION ELECTRODE "PLASMALOOP"
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 11829099
• Report Number: 9610773-2021-00136
• Device Sequence Number: 3832231
• Product Code: FAS
• UDI-Device Identifier: 14042761085134
• UDI-Public: 14042761085134
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2021

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 Model Number: WA22603S
• Device Catalogue Number: WA22603S
• Device Lot Number: 1000056945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR