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

Model Number	SLK-6-LF
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Bander malfunction.Bander misfired on the way out of esophagus on its own.Procedural note: patient who presents to endoscopy for egd to evaluate varices last banded earlier this year.Procedure performed: hb esophagogastroduodenoscopy with variceal band ligation.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.Duodenal bulb was normal.The pylorus was patent.Stomach had cobblestoning of the mucosa.Retroflexed view shows no other abnormality.The squamocolumnar junction was at approximately 38 cm with a nodular inflamed area, likely previous banding.The esophagus had scars and ulcers from previous banding a 2 columns of varices that were banded x4.One band went into the egj area.The scope was slowly withdrawn while suctioning air and fluid.The patient tolerated the procedure well.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 LLC (OLYMPUS); 4740 commercial park ct ste 1; clemmons NC 27012
• MDR Report Key: 8577305
• Report Number: 8577305
• Device Sequence Number: 1638674
• Product Code: FHN
• UDI-Device Identifier: 00850261006033
• UDI-Public: (01)00850261006033(17)201126(10)G11000214
• 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): 04/16/2019
• Report Date (Section F): 04/16/2019

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: G11000214
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 74
• Date Report Sent to FDA: 04/16/2019