MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUS 26F MONOPOLAR RESECTOSCOPE; ENDOSCOPE, AC-POWERED AND ACCESSORIES

Model Number A22202C

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/03/2020

Event Type  malfunction  

Event Description

During the procedure the surgeon stated the resectoscope loop broke off in the patient.

• Brand Name: OLYMPUS 26F MONOPOLAR RESECTOSCOPE
• Type of Device: ENDOSCOPE, AC-POWERED AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 136 turnpike road; southborough MA 01772
• MDR Report Key: 9933186
• MDR Text Key: 186706761
• Report Number: 9933186
• 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: 03/10/2020,03/08/2020

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: A22202C
• Device Catalogue Number: A22202C
• Device Lot Number: 1000037291
• 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: 03/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27740 DA