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

Catalog Number MBL-6

Device Problems Premature Activation (1484); Improper or Incorrect Procedure or Method (2017); Compatibility Problem (2960)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 03/01/2018

Event Type  Injury  

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: the additional information provided indicated that an olympus gif-h190 which has an outer diameter of 9.2 mm.The mbl-6 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 and this may have contributed to premature deployment of bands.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.Use of an endoscope with an outer diameter that is too small may increase the likelihood of the trigger cord being lodged between the barrel and the endoscope.Premature band deployment can also 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 caution 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." 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." 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 for the lot number confirmed that this lot 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 currently being assessed and a follow up report will be sent.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 endoscope was used with the mbl-6 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.All six (6) bands deployed at once [premature band deployment] and the string [trigger cord] could not be detached.The string was now inside the patient.The physician had to slowly back out the endoscope and then reintroduced the endoscope with biopsy forceps and pushed the string down to the ge [gastroesophageal] junction.Additional information was received during a phone conversation on (b)(6) 2018 with the district manager: all six (6) bands deployed at once on the varix.The trigger cord was caught up in the bands on the varix.The physician disengaged the trigger cord from the handle, backed the endoscope out of the patient, leaving the trigger cord in the patient.The physician then placed the endoscope back down the patient and pushed the trigger cord with forceps past the gastroesophageal junction.The trigger cord and the bands were left on the varix to pass naturally.

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.An evaluation of the photos provided by the user could not confirm the report.The photos show the loading catheter, barrel without any bands and two-way handle.The bands and trigger cord were not pictured which made it difficult to perform a complete evaluation.Without return of the device, a complete evaluation could not be performed.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-h190 which has an outer diameter of 9.2 mm.The mbl-6 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 and this may have contributed to premature deployment of bands.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.Use of an endoscope with an outer diameter that is too small may increase the likelihood of the trigger cord being lodged between the barrel and the endoscope.Premature band deployment can also 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 caution 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." 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." 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 for the lot number confirmed that this lot 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 endoscope was used with the mbl-6 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.

• 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: 7371504
• MDR Text Key: 103518068
• Report Number: 1037905-2018-00113
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 00827002225534
• UDI-Public: (01)00827002225534(17)181121(10)W3999408
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• 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: 03/01/2018
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/01/2018
• Date Device Manufactured: 11/21/2017
• 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 Outcome(s): Required Intervention