MAUDE Adverse Event Report: OLYMPUS PLASMA LOOP; ELECTRODE, LOOP

Catalog Number WA227035

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2018

Event Type  malfunction  

Event Description

During prostate resection, using olympus plasma loop, the loop broke in the middle and a piece was floating in the bladder.The provider flushed the bladder and the piece was removed.There was no harm to the patient.

• Brand Name: PLASMA LOOP
• Type of Device: ELECTRODE, LOOP
• Manufacturer (Section D): OLYMPUS; 3500 corporate parkway; center valley PA 18034
• MDR Report Key: 8119210
• MDR Text Key: 128921094
• Report Number: 8119210
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: WA227035
• Device Lot Number: 1000022942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Weight: 98