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); Premature Activation (1484); Compatibility Problem (2960)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: an evaluation of the photos provided by the user was only able to confirm the product and the lot number.Our laboratory evaluation of the product said to be involved could not confirm the report on band deployment difficulty and premature band deployment; however, the evaluation determined delayed band constriction.The trigger cord was attached to the barrel with two (2) bands (one (1) amber and one (1) black band), four (4) deployed black bands, two-way handle, loading catheter and irrigation adapter were included in the return.During our laboratory analysis, the mbl-6-f device was attached to an endoscope that was placed in a simulated esophageal 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-6-f barrel was attached onto the end of the endoscope.Simulated varices were placed at the end of the barrel and vacuum pulled and the bands were deployed.Both bands deployed on the simulated varices; however, both bands took time to constrict and did not securely attach themselves to the varices as intended.During a visual examination of the device, it was observed that the handle was returned in the firing position.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.A loose braid was observed in the trigger cord approximately 164 cm from the distal end.The length of the trigger cord measured within tolerance.The trigger cord was intact and not broken.An evaluation of the handle wheel movement was performed and the wheel functioned as intended.A product specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.Inadequate storage conditions (excessive light and heat), sterilization and/or expired bands could contribute to the properties exhibited during the product evaluation.The band lot number associated with this complaint was researched and it can be concluded that the bands were within the acceptable date range.Therefore, it is unknown why the bands did not constrict as intended.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 this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The additional information provided indicated that an olympus cf-h260ai endoscope was used which has an outer diameter of 13.2 mm.This ligator is compatible with endoscopes that have an outer diameter of 9.5 mm - 13 mm only.Therefore, the ligator was used with an incompatible endoscope.Use of the device with an incompatible endoscope 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 state: "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 additional information received indicated that there was premature deployment of the band.Premature band deployment can occur if the handle is placed in the firing position before the endoscope is in place inside the patient or even while winding the trigger cord.The user is advised not to apply tension to the trigger cord while winding it on the handle to avoid premature deployment of bands.The instructions for use advise the user: ¿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." 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.The instructions for use direct 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." rapid rotation of the ligator handle can contribute to premature band deployment.The instructions for use direct the user: ¿maintain suction and deploy band by rotating handle clockwise until band release is felt, indicating deployment." these bands are stored at our facility to protect against exposure to uv light.In relation to storage conditions, it is advised that the device is kept away from extreme temperatures.The instructions for use advise the user: "store in a dry location, away from temperature extremes." 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 the device was used with an incompatible endoscope, 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 user could not release the first band when the device caught the varix in the esophagus [unable to deploy].The user changed to another of the same product, at once, to finish the procedure considering the patient's safety.The patient lost a small amount of blood and the band slipped off due to the release of the varix for changing the device.Additional information was received on 05/07/2018: the band slipped off the barrel [premature band deployment].

• 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: 7508548
• MDR Text Key: 108545562
• Report Number: 1037905-2018-00197
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 00827002226920
• UDI-Public: (01)00827002226920(17)180621(10)W3878404
• 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: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• 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: 03/21/2018
• Device Age: 9 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2017
• 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: 69 YR
• Patient Weight: 52