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

Catalog Number MBL-6

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 04/30/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report.All kit components were included in the return.The user indicated that an olympus gif hq190 endoscope was used which has an insertion tube outer diameter of 9.9 mm.An endoscope with a similar insertion tube outer diameter was chosen to test the barrel.A pentax eg-2930 endoscope was used with an insertion tube outer diameter of 9.8 mm.The multi-band ligator barrel was attached onto the end of the endoscope.The barrel fit snugly on the end of the endoscope without detaching.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 the reported observation could not be determined because the product said to be involved functioned as intended.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 Description

In preparation for a procedure, the user selected a cook 6 shooter saeed multi-band ligator.At the time the complaint was received on 05/16/2018, there was no information regarding the complaint description available at that time, therefore no reportable information.Additional information was received on 05/22/2018: the six shooter cuff [barrel] kept dropping [off] after [it was] inserted onto the tip of the endoscope.They tried a lot of times [to place the barrel on the tip of the endoscope], but it still dropped off.Another six shooter was used and no problem existed.Additional information was received on 06/04/2018 from the nurse manager: "the endoscope had not gone into the patient yet.After assembling [the device] by the nurses, it [the barrel] dropped off.The physician tried to fix it himself but it also dropped off.I was then called into the procedure room to witness the physician's second attempt to fix the 6 shooter.".

• Brand Name: 6 SHOOTER SAEED MULTI-BAND LIGATOR
• Type of Device: MND, LIGATOR, HEMORRHOIDAL
• 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: 7606386
• MDR Text Key: 112150748
• Report Number: 1037905-2018-00253
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 00827002225534
• UDI-Public: (01)00827002225534(17)181016(10)W3931619
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/30/2018
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2017
• 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