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

Catalog Number MBL-6

Device Problem Detachment Of Device Component (1104)

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

Event Date 02/13/2018

Event Type  malfunction  

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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The additional information stated that the endoscope used was olympus, however the model number is unknown.Without a model number, the outer diameter of the endoscope could not be determined.This ligator is compatible with endoscopes that have an outer diameter of 9.5 mm -13 mm only.A possible contributing factor to barrel detachment is use of an endoscope with an outer diameter outside the range of 9.5 mm -13 mm.The instructions for use state under system preparation: "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." the instructions for use direct the user to: "lubricate endoscope and exterior portion of barrel." the barrel can dislodge if lubricant is applied to the endoscope prior to attaching the barrel or if lubricant is allowed inside the barrel before the loading process.The instructions for use state: "caution: do not place lubricant inside barrel." a possible contributing factor to barrel detachment includes allowing body fluids to enter the area between the barrel and endoscope.The instructions for use state under precautions: "prior to assembling device, routine endoscopic examination is recommended to confirm diagnosis requiring treatment of esophageal varices or internal hemorrhoids." if the endoscope is wiped free after the initial check for location of the varices, body fluids in this area can be avoided.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.

Event Description

During an endoscopic variceal ligation (evl), the physician used a cook 6 shooter saeed multi-band ligator.The plastic piece that holds the bands [barrel] came off the strings [trigger cord] and fell into the patient as the physician was trying to deploy a band.[they were] able to see the plastic piece in the stomach.The same [barrel] was not retrieved by the physician.Additional information was received on 03/22/2018: the whole barrel from the plastic attachment to the endoscope, right through to the strings, fell off the end of the endoscope and into the patient.The physician did not deploy the apparatus when the product detached.

• 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: 7384805
• MDR Text Key: 104250661
• Report Number: 1037905-2018-00121
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 00827002225534
• UDI-Public: (01)00827002225534(17)180919(10)W3920426
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 02/13/2018
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/06/2018
• Date Device Manufactured: 09/19/2017
• 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