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

Model Number	SLK-6-LF
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: (b)(6) 2019.As part of our evaluation, the service center followed up with the user facility and was informed there was no unexpected bleeding reported.It is unknown if the band was retrieved.The intended procedure was completed.No longer stay or additional procedures were required.The device was not returned to the service center for evaluation.The cause of the reported event cannot be determined; however, based on similar reports, the original equipment manufacturer (oem) reported that a potential contributing factor is too much tension applied on the deployment cord.The oem also, reported that an over rotating of the handle during band deployment can cause this type of tension.The instructions for use under "system preparation" states ¿during device setup, putting too much tension on the deployment cord can cause premature band deployment." in addition, the oem reported that the possibility of a band falling off into a patient is considered rare.
Event or Problem Description
The service center received a user facility medwatch form that reports near the end of a hb esophagogastroduodenoscopy with variceal band ligation procedure, the band misfired on its own and fell into the patient¿s esophagogastric junction (egj).The scope was slowly withdrawn while suctioning air and fluid.The patient tolerated the procedure well.It was reported that prior to the incident the surgeon had introduced the video gastroscope into the patient¿s esophagus, stomach and duodenum and observed the following findings: the second and third portion of the duodenum and duodenal bulb were normal and the papilla of vater was seen.The pylorus was patent.The patient¿s stomach had cobblestoning of the mucosa.The retroflexed view showed no other abnormalities.In addition, the patient¿s squamocolumnar junction was approximately at 38cm with a nodular inflamed area as well as scars and ulcers noted on the esophagus which were likely attributed to previous banding.The esophagus had scars and ulcers from previous banding and 2 columns of varices that were banded x 4.
Additional Manufacturer Narrative
This supplemental report is being submitted to report the device evaluation results.The customer returned a slk-6-lf reporting that the device misfired on its own.The device was decontaminated upon being received.The device was captured in its arrival state.The returned parts appear to be intact and have no visual defects.There were two green bands and one blue band returned in the package.The device will be sent to the oem for further investigation.A dhr review was performed and found the lot was built to manufacturing specifications and met manufacturing requirements prior to shipment.
Additional Manufacturer Narrative
This supplemental report is being submitted to report the original equipment manufacturer (oem) device evaluation results.The original equipment manufacturer (oem) performed a secondary physical evaluation.The returned components are the handle, loading device, barrel, 3 elastomer bands, deployment cord (which has been cut), connector tube, and pentax adaptor.The oem reported that all the components were within specification, including the cut deployment cord which was pieced together.The oem reported that the cause of the deployed band is due to user error."over rotating the handle can cause a band to start the deployment process as the endoscope is withdrawn from the esophagus added tension could have caused the band to misfire during endoscope removal." the oem recommended continued customer training/support on proper use of the device.Ensuring the physician knows when the band is deployed by a noticeable tactile sensation.

• Brand Name: SMARTBAND SAFEGRIP MULTI-BAND LIGATION
• Common Device Name: HEMORRHOIDAL LIGATOR
• Manufacturer (Section D): INTELLIGENT ENDOSCOPY LLC.; 4740 commercial prk crt, ste 1; clemmons NC 27012
• MDR Report Key: 8686369
• Report Number: 2951238-2019-00923
• Device Sequence Number: 14081087
• Product Code: MND
• UDI-Device Identifier: 00850261006033
• UDI-Public: (01)00850261006033(17)201126
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2020

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 Expiration Date: 11/26/2020
• Device Model Number: SLK-6-LF
• Device Catalogue Number: IE11004
• Device Lot Number: G11000214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 10/28/2019; 01/28/2020
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 11/18/2019; 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 74