MAUDE Adverse Event Report: SUPERDIMENSION INC. SUPERTRAX BIOPSY FORCEPS

Model Number	AKI00133-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	08/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.The inspection record was reviewed and there were no anomalies observed associated to this issue.Bleeding is a known short term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.
Event or Problem Description
A patient had endobronchial bleeding (100ml) after sampling during an superdimension enb procedure.Local tamponade was applied and thrombin and epi was administered.
Additional Manufacturer Narrative
The inspection record for the needle was reviewed and there were no anomalies observed associated to this issue.

• Brand Name: SUPERTRAX BIOPSY FORCEPS
• Common Device Name: BIOPSY FORCEPS
• Manufacturer (Section D): SUPERDIMENSION INC.; 161 cheshire lane; suite 100; minneapolis MN 55441
• MDR Report Key: 5969640
• Report Number: 3004962788-2016-00251
• Device Sequence Number: 16241077
• Product Code: FCL
• UDI-Device Identifier: 20884521200484
• UDI-Public: 20884521200484
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K925392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: AKI00133-01
• Device Lot Number: 252847
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2016
• Supplement Report FDA Received Date: 09/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR