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

Model Number A22201C

Patient Problem Foreign Body In Patient (2687)

Event Date 08/14/2023

Event Type  malfunction  

Event Description

During a turp (transurethral resection of the prostate) procedure, the monopolar resection loop broke during use.X-ray identified piece of loop within the bladder.No patient harm reported by surgeon.Procedure was completed.

• Brand Name: HF-RESECTION ELECTRODE
• Type of Device: ENDOSCOPE, AC-POWERED AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; 800 west park drive; westborough MA 01581
• MDR Report Key: 17718685
• MDR Text Key: 323050369
• Report Number: 17718685
• Device Sequence Number: 1
• Product Code: GCP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/08/2023,09/06/2023

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
• Device Operator: Health Professional
• Device Model Number: A22201C
• Device Catalogue Number: A22201C
• Device Lot Number: 1000112793
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Sex: Male