MAUDE Adverse Event Report: RICHARD WOLF GERMANY (GMBH) BOA VISION FLEXIBLE SENSOR URETERO-RENOSCOPE; FLEXIBLE URETERO-RENOSCOPE

Model Number 7355071

Device Problem Folded (2630)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/26/2016

Event Type  Injury  

Event Description

Richard wolf medical instruments corporation (rwmic) was notified by a company representative that device in question was stuck inside of a patient.Excessive force was needed to remove device from patient.No injury to patient reported.Device in question was returned to rwmic on 05/24/2016 and will be sent to manufacturer on or around 06/01/2016.Facility has been contacted in effort to gather missing information, no response as of 05/25/2016.Rwmic considers this matter closed.However, in the event additional information is received, rwmic will provide manufacturer with information.

• Brand Name: BOA VISION FLEXIBLE SENSOR URETERO-RENOSCOPE
• Type of Device: FLEXIBLE URETERO-RENOSCOPE
• Manufacturer (Section D): RICHARD WOLF GERMANY (GMBH); registration #9611102; 32 pforzheimer street; knittlingen 75438 ; GM 75438
• MDR Report Key: 5680009
• MDR Text Key: 45959905
• Report Number: 1418479-2016-00011
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2016,04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 7355071
• 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: 05/25/2016
• Distributor Facility Aware Date: 04/27/2016
• Device Age: 1 YR
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 05/25/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other