MAUDE Adverse Event Report: OLYMPUS WINTER IBE GMBH OLYMPUS; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number WA22607D

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2019

Event Type  malfunction  

Event Description

While the doctor was using the button turp loop, the loop broke while cauterizing the prostate.The ends of the loop curled up.Entire loop is still there, just curled up at the ends.New loop obtained and the procedure continued with no harm to patient.

• Brand Name: OLYMPUS
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): OLYMPUS WINTER IBE GMBH; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8296547
• MDR Text Key: 134727078
• Report Number: 8296547
• Device Sequence Number: 1
• Product Code: NLW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22607D
• Device Catalogue Number: WA22607D
• Device Lot Number: 806847
• 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: 01/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Weight: 102