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

Catalog Number	MBL-6-XL-C
Medical Device Problem Codes	Premature Activation (1484); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: non-healthcare professional.Continued from section event problem and evaluation codes: conclusion code - cause not established.Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved could not confirm the report.The barrel was the only portion included in the return.During a functional test, the barrel was loaded onto a pentax ec-3830tl scope with a 12.8 mm outer diameter.The barrel fit snugly on the end of the endoscope without detachment.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: a definitive cause for this observation could not be determined because the actual prior to use testing conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.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." 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 or Problem Description
In preparation for a procedure, the user selected a cook 6 shooter saeed multi-band ligator.The note on the box says that it will not fit on the tip of the endoscope.Lot # w4094748.There was no reportable information at this time.Additional information was received on (b)(6) 2018: the bander [barrel] failed to stay on the endoscope, it kept falling off.Additional information was received on (b)(6) 2018: [the barrel kept falling off] after being placed on the endoscope but prior to being introduced into the patient.It would not fit on the end of the endoscope.[the device] shot off two (2) or three (3) bands [premature band deployment].The device was not used.This occurred prior to patient contact; there was no impact to the patient.

• Brand Name: 6 SHOOTER SAEED MULTI-BAND LIGATOR
• Common Device Name: MND, LIGATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7960810
• Report Number: 1037905-2018-00479
• Device Sequence Number: 1488239
• Product Code: MND
• UDI-Device Identifier: 00827002252219
• UDI-Public: (01)00827002252219(17)190717(10)W4094748
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/17/2019
• Device Catalogue Number: MBL-6-XL-C
• Device Lot Number: W4094748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR