MAUDE Adverse Event Report: COOK ENDOSCOPY 4 SHOOTER SAEED MULTI-BAND LIGATOR; MND, LIGATOR, ESOPHAGEAL

Catalog Number	MBL-U-4
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.Band deployment difficulty can occur if the endoscope accessory channel is compromised.In these cases, the endoscope accessory channel collapses, restricting the trigger cord and preventing proper band deployment.The instructions for use contain the following statement: "use of an endoscope in a sound state of repair is a prerequisite for a successful multi-band ligation procedure." band deployment difficulty can occur if the trigger cord is not properly seated in the handle assembly.The instructions for use advise the user: "note: knot must be seated into hole or handle will not function properly." a precaution in the instructions for use states: "it is vital that the integrity of the working channel is intact as grooves or other obstructions in the working channel can potentially cause the string to catch, resulting in band deployment difficulty." system preparation in the instructions for use states: "attach barrel to tip of endoscope, ensuring barrel is advanced onto tip as far as possible.Note: when placing the barrel onto the distal end of the endoscope, ensure that the trigger cord does not become pinched between the barrel and the endoscope." prior to distribution, all 4 shooter saeed multi-band ligators are subjected to a visual inspection to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Event or Problem Description
During an endoscopic variceal ligation (evl), the physician used a cook 4 shooter saeed multi-band ligator.There was no resistance when trying to shoot off the rubber rings [difficulty deploying bands], tube of the product corkscrewed.Additional information received on 10/27/2017: when starting to deploy the second band, some resistance was felt at the handle.The band could not be deployed [unable to deploy band].The endoscope itself got twisted like a cork-screw [endoscope torqueing].The endoscope with the device was taken out and a new mbl-u-4 was mounted on the endoscope.The procedure was successfully finished with this device.

• Brand Name: 4 SHOOTER SAEED MULTI-BAND LIGATOR
• Common Device Name: MND, LIGATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7042716
• Report Number: 1037905-2017-00692
• Device Sequence Number: 19182129
• Product Code: MND
• UDI-Device Identifier: 00827002319158
• UDI-Public: (01)00827002319158(17)180519(10)W3868191
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

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 Catalogue Number: MBL-U-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/24/2017
• Device Age: 5 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1