MAUDE Adverse Event Report: INTELLIGENT ENDOSCOPY SMARTBAND MULTI-BAND LIGATION KIT; BAND, HEMORRHOID

Catalog Number IE11004

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

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

Event Date 07/31/2019

Event Type  malfunction  

Event Description

While preforming an egd on this patient treatment of esophageal varices was warranted.Upon using the smart band multi-band ligation kit made by intelligent endoscopy we placed 1 band and it did fine.However, we placed a second band with proper suction, just as it was supposed to be preformed.It looked really good and then right in front of us the band popped off of the varices.This happening had a potential to cause a massive gi bleed had we not noticed it when it happened, doctor was very upset.Device not saved.Operative note.Preoperative diagnosis: gi bleed.Postoperative diagnosis: esophageal varices (small, no stigmata of recent bleeding - banded x2, one came off); severe portal gastropathy.Procedure performed: egd.Complications: none.Estimated blood loss: less than 5 ml.Procedure findings: egd: with the patient properly sedated and in left lateral decubitus, the gastroscope was introduced through the mouth without difficulty.No visible abnormalities of the vocal cords and the oropharynx.The esophagus presented some scarring due to previous banding and 2 small varices - they were both banded but one band came off.There was a medium size hiatus hernia in retroflexion.The fundus, antrum and corpus presented diffuse and severe aspects of portal gastropathy.Normal bulb and second portion of the duodenum.Esophageal varices (small - banded x2, one came off); severe portal gastropathy.The latter could be responsible for microscopic bleeding.Management per gi team.Condition of patient: the patient was transferred in stable condition.

• Brand Name: SMARTBAND MULTI-BAND LIGATION KIT
• Type of Device: BAND, HEMORRHOID
• Manufacturer (Section D): INTELLIGENT ENDOSCOPY; 4740 commercial park ct ste 1; clemmons NC 27012
• MDR Report Key: 8926137
• MDR Text Key: 155372834
• Report Number: 8926137
• Device Sequence Number: 1
• Product Code: FHN
• 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: 08/01/2019,07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IE11004
• Device Lot Number: G11000248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Weight: 91