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

Catalog Number MBL-6

Device Problems Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017); Compatibility Problem (2960)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.The two-way handle, trigger cord attached to the barrel with five (5) bands, and the loading catheter were included in the return.One (1) band was not included in the return.The irrigation adapter was also not included in the return.During a functional test, the barrel was attached to the end of a pentax eg-2930 endoscope with an insertion tube outer diameter of 9.8 mm.The barrel fit the end of the endoscope as intended and did not detach.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.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 information provided from the user facility confirmed the endoscope used during the procedure was an olympus gif-h190.The endoscope has an outer diameter of 9.2 mm.The mbl-6 requires an endoscope outer diameter size of 9.5 mm - 13 mm, therefore this device was used with an incompatible endoscope.Use of the product with an incompatible endoscope can result in the barrel being loose on the endoscope.This is the most likely cause for the reported observation.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 device, 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

In preparation for a procedure, the user selected a cook 6 shooter saeed multi-band ligator.The cap [barrel] was too big.There was no reportable information at this time.Additional information was received from the district manager (dm) on (b)(6) 2018: the dm indicated that the device did not make contact with the patient but did make contact with the endoscope.The scope is an olympus 190 series.The cap [barrel] would slide off of the endoscope.A new mbl-6 was opened and used.It worked just fine to complete the procedure.This occurred prior to patient contact; there was no impact to 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 (Section G): 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: 7648431
• MDR Text Key: 113020447
• Report Number: 1037905-2018-00281
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 00827002225534
• UDI-Public: (01)00827002225534(17)190404(10)W4051992
• 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,user f
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2019
• Device Catalogue Number: MBL-6
• Device Lot Number: W4051992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2018
• 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