MAUDE Adverse Event Report: RICHARD WOLF GMBH; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number 815053

Device Problems Break (1069); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 11/17/2020

Event Type  malfunction  

Event Description

Transurethral resection of prostate.Heard a loud "pop", monopolar cord broke at end where is connects to the resectoscope.Wolf rep reported there are not a specific number of uses but if any visible damage is found, to then replace the cord.All of these cords are being replaced on trays.Defective monopolar cord saved for quality.

• Brand Name: NA
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): RICHARD WOLF GMBH; 353 corporate woods pkwy; vernon hills IL 60061
• MDR Report Key: 11139184
• MDR Text Key: 225754283
• Report Number: 11139184
• Device Sequence Number: 1
• Product Code: GEI
• 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: 12/14/2020,12/11/2020

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: 815053
• Device Catalogue Number: 815.053
• 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: 12/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Weight: 76