MAUDE Adverse Event Report: INTELLIGENT ENDOSCOPY SMARTBAND SAFEGRIP MULTI-BAND LIGATION KIT; LIGATOR, HEMORRHOIDAL

Model Number	SLK-6-LF
Health Effect - Clinical Codes	Erythema (1840); Foreign Body In Patient (2687)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Band fell off of esophageal varices after it was deployed.The patient was brought to the endoscopy room where the procedures were being done today.Anesthesia was administered and well tolerated.The patient was placed in the left lateral decubitus position.Inspection of the hypopharynx showed normal vocal cords without reflux injury or neoplasm.The video gastroscope was introduced into the esophagus, stomach, and duodenum with the following findings: the second and third portion of the duodenum were normal and the papilla of vater was seen.Stomach had cobble stoning and erythema.Retroflexed view shows no other abnormality.The squamocolumnar junction was at approximately 40 cm.The esophagus had 4 columns of mid grade varices.6 bands were deployed, one slipped off and a second set was used to replace that band.The scope was slowly withdrawn while suctioning air and fluid.The patient tolerated the procedure well.

• Brand Name: SMARTBAND SAFEGRIP MULTI-BAND LIGATION KIT
• Common Device Name: LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): INTELLIGENT ENDOSCOPY; 4740 commercial park ct ste 1; clemmons NC 27012
• MDR Report Key: 8869311
• Report Number: 8869311
• Device Sequence Number: 16644372
• Product Code: FHN
• UDI-Device Identifier: 00850261006033
• UDI-Public: (01)00850261006033(17)210114(10)G11000231
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2019
• Report Date (Section F): 07/16/2019

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
• Operator of Device: Health Professional
• Device Model Number: SLK-6-LF
• Device Catalogue Number: IE11004
• Device Lot Number: G11000231
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 75
• Date Report Sent to FDA: 07/16/2019