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

Catalog Number	MBL-4
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: an evaluation of the photo provided by the user of the barrel with trigger cord attached confirmed the report on a knot/loop in the trigger cord.Our evaluation of the returned device confirmed the report.The product received was returned in an opened tray.The only portion of the device that was returned was the trigger cord attached to the barrel with all four (4) bands - three (3) black and one (1) amber band.The two-way handle, irrigation adapter and loading catheter were not included in the return of the device.A visual examination of the device showed that the trigger cord attached to the barrel was in the opposite direction.It was also observed that the first set of beads on the trigger cord had slipped under the first black band and a bead from the second set of beads behind the second black band had moved from one side of the barrel to the other side forming a loose loop in the trigger cord.We were unable to determine how the string became looped.A functional test was further performed to test a 4 shooter saeed multi-band ligator band deployment using a loading catheter and two-way handle from our laboratory supply.During our laboratory analysis, the mbl device was attached to an endoscope that was placed in a simulated gastro-intestinal position with vacuum attached.The endoscope has an accessory channel that is 2.8 mm in diameter (olympus 2.8 gif q20 endoscope).The mbl barrel was attached onto the end of the scope.Simulated varices were placed at the end of the barrel, vacuum pulled and each band was fired.The first and second black bands deployed together on the first simulated varix indicating premature deployment of the second band.The two bands took time to constrict.The amber band and last black band deployed as intended on simulated varices.The trigger cord was examined and all eight (8) deployment beads were present.The beads were verified for correct location.The beads were examined using magnification and found to be correctly filled and had no evidence of excess flash.The length of the trigger cord measured within tolerance.The trigger cord was intact and not broken.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.The lot number associated with this complaint was researched to determine the manufacturing date of the bands.We can conclude from these dates that the bands were within the acceptable age date range to ensure the bands maintain their elasticity properties.The subassembly 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.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 actual product handling conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.The trigger cord was returned attached to barrel in the opposite direction.The user is advised to visually inspect the device prior to using it.The instructions for use advise the user: "if package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." the instructions for use also advise the user: ¿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." during a functional test the first two ligator bands deployed prematurely on the first varix.Rapid rotation of the ligator handle can contribute to premature band deployment.Premature deployment can also occur while winding the trigger cord.The instructions for use caution the user under system preparation: "with handle in two way position, slowly rotate handle clockwise to wind trigger cord onto handle spool until it is taut.Note: care must be taken to avoid deploying a band while winding trigger cord." premature band deployment can also occur if the endoscope working channel was compromised.The instructions for use caution the user: ¿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.¿ the instructions for use also caution the user: ¿use of an endoscope in a sound state of repair is a prerequisite for a successful multi-band ligation procedure.¿ another 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.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 and this represents an isolated occurrence.The likelihood of occurrence is considered remote.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
In preparation for a procedure, the user selected a cook 4 shooter saeed multi-band ligator.When the nurse installed the device, she found the string of the cap is in the wrong position.The nurse told the physician and it was changed to another device.Then, the second device was okay.On (b)(6)2017, the device was evaluated via simulated testing.It was found that the bands deployed prematurely.

• 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: 6627834
• Report Number: 1037905-2017-00361
• Device Sequence Number: 10963127
• Product Code: MND
• UDI-Device Identifier: 00827002226135
• UDI-Public: (01)00827002226135(17)171114(10)W3796449
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2017

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-4
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/28/2017
• Device Age: 5 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2017
• Initial Report FDA Received Date: 06/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 75