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

Model Number SLK-6-LF

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Erythema (1840); Foreign Body In Patient (2687)

Event Date 06/10/2019

Event Type  malfunction  

Event 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varices.6 bands were deployed, one slipped off and a second set was used to replace that band.The scope was slowly withdrawn while suctioning air and fluid.The patient tolerated the procedure well.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
• Type of Device: LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): INTELLIGENT ENDOSCOPY; 4740 commercial park ct ste 1; clemmons NC 27012
• MDR Report Key: 8869311
• MDR Text Key: 153545908
• Report Number: 8869311
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 00850261006033
• UDI-Public: (01)00850261006033(17)210114(10)G11000231
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SLK-6-LF
• Device Catalogue Number: IE11004
• Device Lot Number: G11000231
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13505 DA
• Patient Weight: 75