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

Model Number SBC-365

Device Problems Fluid/Blood Leak (1250); Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2017

Event Type  malfunction  

Manufacturer Narrative

As of the date of this report, no product has been returned to the manufacturer for evaluation.If additional information is obtained, it will be provided in a supplementary report.

Event Description

It was reported that during a colonoscopy that involved rectal bleeding, a biopsy valve leaked and blood splattered on attending healthcare personnel.The case was successfully completed and there was no reported injury or other adverse health consequence to the patient.

• Brand Name: SEAL BIOPSY VALVE
• Type of Device: DISPOSABLE BIOPSY VALVE
• Manufacturer (Section D): ENDOCHOICE, INC.; 11810 wills road; alpharetta GA 30009 2081
• Manufacturer (Section G): ENDOCHOICE, INC.; 11810 wills road; alpharetta GA 30009 2081
• Manufacturer Contact: daniel hoefer ; 11810 wills road; alpharetta, GA 30009-2081 ; 6787084743
• MDR Report Key: 6603208
• MDR Text Key: 76399954
• Report Number: 3007591333-2017-00031
• 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: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• 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-365-100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2017
• 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