MAUDE Adverse Event Report: SCANLAN INTERNATIONAL INC SCANLAN® RONGEUR

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 02/02/2017

Event Type  malfunction  

Event Description

The #1 kerrison from the tannoury basic kit it #005 broke off.

• Brand Name: SCANLAN® RONGEUR
• Type of Device: RONGEUR
• Manufacturer (Section D): SCANLAN INTERNATIONAL INC; one scanlan plaza; saint paul MN 55107
• MDR Report Key: 6379902
• MDR Text Key: 69128629
• Report Number: 6379902
• Device Sequence Number: 1
• Product Code: HTX
• 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: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Other Device ID Number: KERRISON RONGEUR; 1001-904
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1