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

Model Number SLK-6-LF

Device Problem Misfire (2532)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2019

Event Type  malfunction  

Event 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from previous banding a 2 columns of varices that were banded x4.One band went into the egj area.The scope was slowly withdrawn while suctioning air and fluid.The patient tolerated the procedure well.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
• Type of Device: LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): INTELLIGENT ENDOSCOPY LLC (OLYMPUS); 4740 commercial park ct ste 1; clemmons NC 27012
• MDR Report Key: 8577305
• MDR Text Key: 143980411
• Report Number: 8577305
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 00850261006033
• UDI-Public: (01)00850261006033(17)201126(10)G11000214
• 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: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• 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: G11000214
• 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: 04/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18250 DA
• Patient Weight: 74