MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. E-LINE; RESECTOSCOPE, WORKING ELEMENT

Model Number 8655334

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/20/2017

Event Type  malfunction  

Event Description

The surgeon was using the device during a hysteroscopy procedure and it broke inside of the body cavity during the procedure.

• Brand Name: E-LINE
• Type of Device: RESECTOSCOPE, WORKING ELEMENT
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods pkwy.; vernon hills IL 60061
• MDR Report Key: 6460166
• MDR Text Key: 71718999
• Report Number: 6460166
• Device Sequence Number: 1
• Product Code: FDC
• 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: 03/22/2017

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: 8655334
• Device Catalogue Number: 8655.334
• Other Device ID Number: 22.5/24.5
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES