MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE

Model Number	A22201C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: hf-resection electrode, loop, 24 fr., 0.35 wire, 12°, sterile, single use, 12 pcs.Pma/510k: k790071/ k903323/ k951863/ k954488/ k931763/ k931764.The suspect device has not been returned to olympus for evaluation.The investigation was based on the information provided by the customer.A dhr review cannot be performed since the lot number is unknown.However, the manufacturing and quality control review was performed for the last 24 months of production and there are no non-conformities or deviations regarding the described issue.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to wear and tear.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.The instructions for use state a suitable replacement device must be provided during an application.Not returned to manufacturer.
Event or Problem Description
The customer reported to olympus the resectoscope loop broke intraoperatively during use.The customer reported no adverse event or harm to the patient.Additional information was requested of the customer.However no additional information was provided.It is unknown if the broken loop fell into the patient.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE
• Common Device Name: HF-RESECTION ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 12309241
• Report Number: 9610773-2021-00221
• Device Sequence Number: 17118757
• Product Code: GCP
• UDI-Device Identifier: 14042761036648
• UDI-Public: 14042761036648
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/11/2021

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: A22201C
• Device Catalogue Number: A22201C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1