MAUDE Adverse Event Report: WOLF; RESECTOSCOPE

Model Number 8974.402

Device Problems Thermal Decomposition of Device (1071); Melted (1385)

Patient Problem No Information (3190)

Event Date 05/05/2016

Event Type  malfunction  

Event Description

The surgeon put the device together to test and it burned/melted the device.We were unable to use during the procedure.There was a possible error when connecting the device.

• Type of Device: RESECTOSCOPE
• Manufacturer (Section D): WOLF; 353 corporate woods parkway; vernon hills IL 60061
• MDR Report Key: 5754711
• MDR Text Key: 48314485
• Report Number: 5754711
• Device Sequence Number: 1
• Product Code: FJL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2016

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: Physician
• Device Model Number: 8974.402
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1