MAUDE Adverse Event Report: ENDOCHOICE INC. SEAL; BIOPSY VALVE FOR FLEXIBLE ENDOSCOPY

Model Number SBC-365

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2018

Event Type  malfunction  

Manufacturer Narrative

Devices were not returned to the manufacturer.No further evaluation is possible at this time.

Event Description

The complainant stated that small fragments of the biopsy valve entered the patient during a procedure.No intervention was deemed necessary, and no other negative health consequence to the patient was reported.

• Brand Name: SEAL
• Type of Device: BIOPSY VALVE FOR FLEXIBLE ENDOSCOPY
• Manufacturer (Section D): ENDOCHOICE INC.; 11810 wills road; alpharetta 30009
• Manufacturer (Section G): ENDOCHOICE INC.; 11810 wills road; alpharetta 30009
• Manufacturer Contact: aisha hannah ; 11810 wills road; alpharetta 30009 ; 6787084747
• MDR Report Key: 7209391
• MDR Text Key: 98193211
• Report Number: 3007591333-2018-00005
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: SBC-365
• Device Catalogue Number: SBC-365-S
• Device Lot Number: 170918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/18/2017
• 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