MAUDE Adverse Event Report: SUPERDIMENSION INC. SUPERTRAX BIOPSY FORCEPS

Model Number AKI00133-01

Device Problems Break (1069); Component Missing (2306); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2014

Event Type  Injury  

Event Description

During a superdimension procedure the biopsy forceps broke and a piece broke off.The broken piece was missing.The site used fluoro and performed a ct scan to confirm the missing piece was not left in the pt, and both were negative.There was no injury or serious adverse event to the pt and the pt was released.The surgeon stated he does not believe there is a foreign body retained.

Manufacturer Narrative

The device has been requested but to date the device has not been received for eval.If additional info is received a follow up report will be submitted.

• Brand Name: SUPERTRAX BIOPSY FORCEPS
• Type of Device: BIOPSY FORCEPS
• Manufacturer (Section D): SUPERDIMENSION INC.; 161 cheshire lane; minneapolis MN 55441
• Manufacturer Contact: sharon murphy ; 161 cheshire lane; suite 100; minneapolis, MN 55441 ; 2034925267
• MDR Report Key: 3987540
• MDR Text Key: 4637438
• Report Number: 3004962788-2014-00036
• Device Sequence Number: 1
• Product Code: FCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AKI00133-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other