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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENDOCHOICE INC. SEAL BIOPSY VALVE; DISPOSABLE BIOPSY VALVE
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ENDOCHOICE INC. SEAL BIOPSY VALVE; DISPOSABLE BIOPSY VALVE Back to Search Results
Model Number SBC-580
Device Problems Fluid/Blood Leak (1250); Device Issue (2379)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The reporting facility indicated the device was not available for return.
 
Event Description
It was reported that during a procedure, the cap of the seal device opened resulting in feces spraying into the face of attending healthcare personnel.The case was completed and there was no reported injury or other adverse health consequence to the patient.
 
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Brand Name
SEAL BIOPSY VALVE
Type of Device
DISPOSABLE BIOPSY VALVE
Manufacturer (Section D)
ENDOCHOICE INC.
11810 wills road
alpharetta 30009 2081
Manufacturer (Section G)
ENDOCHOICE, INC.
11810 wills road
alpharetta 30009 2081
Manufacturer Contact
aisha hannah
11810 wills road
alpharetta 30009-2081
6787084747
MDR Report Key7626837
MDR Text Key112469327
Report Number3007591333-2018-00026
Device Sequence Number1
Product Code OCX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111821
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 06/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberSBC-580
Device Catalogue NumberSBC-580
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/22/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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