MAUDE Adverse Event Report: ENDOCHOICE, INC. SEAL BIOPSY VALVE; DISPOSABLE BIOPSY VALVE

Model Number SBC-365

Device Problem Device Issue (2379)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 07/19/2016

Event Type  malfunction  

Manufacturer Narrative

It was determined that the material in the patient was as a result of the user causing pieces of the valve to tear off and be pushed down the channel with the biopsy forceps.

Event Description

It was reported that during procedures when biopsy forceps were passed down the channel, blue material would pass through to the patient's colon.The physician would remove the material using forceps.There was no patient injury or other adverse health consequence reported.

• Brand Name: SEAL BIOPSY VALVE
• Type of Device: DISPOSABLE BIOPSY VALVE
• Manufacturer (Section D): ENDOCHOICE, INC.; 11810 wills road; alpharetta GA 30009
• Manufacturer (Section G): ENDOCHOICE, INC.; 11810 wills road; alpharetta GA 30009
• Manufacturer Contact: daniel hoefer ; 11810 wills road; alpharetta, GA 30009 ; 6787084743
• MDR Report Key: 5884316
• MDR Text Key: 52384326
• Report Number: 3007591333-2016-00043
• Device Sequence Number: 1
• Product Code: OCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111821
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SBC-365
• Device Catalogue Number: SBC-365-100
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention