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

Model Number	SLK6LF
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Date of Event	11/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported that during a patient procedure user facility personnel were treating esophageal varices by placing six elastic ligation bands.The user observed bleeding in the patient which resulted in a blood transfusion.The user facility reported that the patient is fine and has since returned home.
Additional Manufacturer Narrative
Through follow-up with the distributor, steris endoscopy learned that the user facility stated that the ligation bands were too stiff.The distributer offered in-service training to the user facility on the proper use and operation of the ligation bands however, the user facility declined.The instructions for use (ifu) gives the user the following information to the user: "if package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If abnormality is detected that would prohibit proper working condition, do not use.Please notify intelligent endoscopy for return authorization.Olympus/fujifilm endoscopes: insert handle stem with preloaded universal connector into accessory channel port ensuring it forms a complete seal and secure fit around the metal port.Note: keep the deployment cord clear of the barrel and endoscope, so that it does not become caught.Lubricate endoscope and exterior portion of barrel.Caution: do not place lubricant inside of barrel.Caution: do not apply alcohol to device." steris requested the device(s) subject of the reported event be returned for evaluation however, the user facility stated that the device is not available.Without the return of the device(s), steris is unable to determine the cause of the reported event.The device history record was reviewed, and no abnormalities were identified.A complaint review was conducted for this lot and indicates this to be an isolated event.

• Brand Name: SMARTBAND SAFEGRIP MULTI-BAND LIGATION KIT
• Common Device Name: LIGATOR
• Manufacturer (Section D): INTELLIGENT ENDOSCOPY; 4740 commercial park ct ste 1; clemmons NC 27012
• Manufacturer (Section G): INTELLIGENT ENDOSCOPY; 4740 commercial park ct ste 1; clemmons NC 27012
• Manufacturer Contact: coletta cohara ; 4740 commercial park ct ste 1; clemmons, NC 27012 ; 4403586251
• MDR Report Key: 15898150
• Report Number: 3011324403-2022-00002
• Device Sequence Number: 17411202
• Product Code: MND
• UDI-Device Identifier: 00850261006033
• UDI-Public: 00850261006033
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SLK6LF
• Device Catalogue Number: IE11004
• Device Lot Number: 4054201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown