MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP; ENDOSCOPES, AC-POWERED AND ACCESSORIES

Model Number A22201C

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/15/2022

Event Type  Injury  

Event Description

Olympus received a voluntary mw reporting an unspecified procedure during which a resection electrode loop 24f broke inside the patient.Olympus is unable to request additional details regarding the patient or reported event, the reporter requested identity and contact information remain confidential.The device will not be returned for evaluation.

• Brand Name: HF-RESECTION ELECTRODE, LOOP
• Type of Device: ENDOSCOPES, AC-POWERED AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22014 5; GM 220145
• MDR Report Key: 15739443
• MDR Text Key: 303181937
• Report Number: 2429304-2022-00107
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 14042761036648
• UDI-Public: 14042761036648
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 10/07/2022,11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2023
• Device Model Number: A22201C
• Device Catalogue Number: A22201C
• Device Lot Number: 1000033994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/07/2022
• Date Report to Manufacturer: 10/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other