MAUDE Adverse Event Report: COOK ENDOSCOPY 6 SHOOTER SAEED MULTI-BAND LIGATOR; MND, LIGATOR, ESOPHAGEAL

Catalog Number MBL-6

Device Problem Positioning Failure (1158)

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

Event Date 06/27/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our evaluation of the product said to involved could not confirm the report as described.The product returned included the trigger cord, two-way handle, and friction-fit adapter.The elastic bands were not included in the return.An evaluation of the handle wheel movement was performed and the wheel functioned as intended.A visual examination of the trigger cord was performed and all twelve (12) beads were present.The twelve (12) beads were examined and all twelve (12) beads were correctly filled.The location of the beads were verified and all twelve (12) beads were in the correct location.The length of the trigger cord was measured to be within specification.The trigger cord was intact and not broken.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: a definitive cause for the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.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." a possible contributing factor to premature band deployment includes allowing the trigger cord to become lodged between the barrel and the distal end of the endoscope.This can restrict trigger cord movement and result in premature band deployment if enough tension is applied to pull the cord free.The instructions for use directs the user to "maintain suction and deploy band by rotating handle clockwise until band release is felt, indicating deployment.¿ prior to distribution, all 6 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 Description

During an endoscopic procedure, the physician used a cook 6 shooter saeed multi-band ligator.The following was reported to cook customer relations "during the operation [procedure] of tying the endoscopic esophageal varices [ligation], after having sucked in the varix into the transparent cap [barrel], turning the knob the lace has not been expelled [band would not deploy].The maneuver didn't create injuries on the varix, but this could have caused possible and serious bleeding with significant risk for the patient.".

• Brand Name: 6 SHOOTER SAEED MULTI-BAND LIGATOR
• Type of Device: MND, LIGATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 5834909
• MDR Text Key: 50817269
• Report Number: 1037905-2016-00274
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 00827002225534
• UDI-Public: (01)00827002225534(17)170314(10)W3696013
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MBL-6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/27/2016
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 07/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR