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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENDOCHOICE, INC. SEAL®; ENDOSCOPIC IRRIGATION/SUCTION SYSTEM
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ENDOCHOICE, INC. SEAL®; ENDOSCOPIC IRRIGATION/SUCTION SYSTEM Back to Search Results
Model Number SBC-365
Device Problems Material Fragmentation (1261); Device Contamination with Chemical or Other Material (2944)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/05/2019
Event Type  malfunction  
Event Description
When taking a biopsy of the stomach a tiny blue particle was noticed on the biopsy forceps.Forceps were immediately removed and particle placed on 4x4 for staff to obtain a picture.On another pass another particle was noticed in the patient's stomach.It was presumed that it came from the biopsy cap as it was the only blue artificial item in the path the biopsy forceps took.The device was saved and will be returned for failure analysis.The additional blue particle was retrieved and no harm came to the patient.Microscope images were obtained from the biopsy cap and are attached to this report.
 
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Brand Name
SEAL®
Type of Device
ENDOSCOPIC IRRIGATION/SUCTION SYSTEM
Manufacturer (Section D)
ENDOCHOICE, INC.
300 boston scientific way
marlborough MA 01752
MDR Report Key8499638
MDR Text Key141479622
Report Number8499638
Device Sequence Number0
Product Code OCX
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/25/2019,02/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2019
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberSBC-365
Device Lot Number170425
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/25/2019
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer04/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age4745 DA
Patient Weight41
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