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

Catalog Number MBL-6-F

Device Problems Positioning Failure (1158); Compatibility Problem (2960)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in an open plastic tray from the lot number provided in the report.The label matches the product returned.Photos were provided and reviewed.An evaluation of the seven (7) photos provided by the user could not confirm the report.The photos provided show the successful suction and deployment of elastic bands on esophageal varices.Our laboratory evaluation of the product said to be involved could not confirm the report.The trigger cord attached to the barrel with one (1) black band, two-way handle and irrigation adapter were included in the return.The loading catheter and five (5) bands were not included in the return.The two-way handle was returned in the firing position.A functional test was performed on the returned device to test the deployment of the single black band returned on the barrel.A loading catheter from our shelf stock was used to evaluate the returned device.The multi-band ligator device was attached to an endoscope that was placed in a simulated gastrointestinal position with vacuum attached.The endoscope has an accessory channel that is 2.8 mm in diameter (olympus 2.8 gif q20 endoscope).The multi-band ligator barrel was attached onto the end of the endoscope.A simulated varix was placed at the end of the barrel, vacuum pulled and the black band was successfully fired.The black band deployed and constricted as intended on the simulated varix.A visual examination of the device was performed.The trigger cord was examined and all twelve (12) 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 was measured within tolerance.The trigger cord was intact and not broken.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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: the additional information provided indicated that an olympus gif-h290 diagnostic video gastroscope was used.This endoscope has an insertion tube outer diameter of 8.9 mm.The mbl-6 requires an endoscope outer diameter size of 9.5 mm - 13 mm.The labeling on the device lists the recommended endoscope size for each reference part number (rpn).In addition, the mbl-6-f devices are recommended to be used with fujinon endoscopes because they have a longer trigger cord.Use of the device with an incompatible scope could have contributed to the reported observation.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 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.Additional comments regarding this report: based on the information provided that an incompatible scope was used, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

Event Description

During an endoscopic variceal ligation (evl), the physician used a cook 6 shooter saeed multi-band ligator.The operator could not release the last band during the operation.The string [trigger cord] snapped then they withdrew the device.Additional information was received on 03/29/2018: the trigger cord is attached with the band [to the barrel] as the operator cannot pull it off during the procedure with the last band.The picture of the returned device demonstrates the trigger cord is attached to the barrel with the last band.The returned device was received with the trigger cord attached to the barrel.

• 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: 7445111
• MDR Text Key: 106302361
• Report Number: 1037905-2018-00158
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 00827002226920
• UDI-Public: (01)00827002226920(17)190122(10)W4021734
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MBL-6-F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/15/2018
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2018
• 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: 40 YR
• Patient Weight: 80