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 Problem Foreign Body In Patient (2687)

Event Date 02/09/2018

Event Type  Injury  

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in an open tray 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 device return included the trigger cord wound on the two-way handle, the barrel, two (2) deployed bands (one (1) black and one (1) amber), the loading catheter and the irrigation adapter.The barrel was attached to an olympus 2.8 mm channel gif q20 endoscope with an outer diameter of 11 mm and the barrel fit snugly on the endoscope without detaching.The inner diameter of the barrel was inspected and the barrel and found to be within acceptance range.The trigger cord was examined and all twelve (12) deployment beads were present.The beads were verified for correct location.Both knots were present on the trigger cord and the length was measured within tolerance.The trigger cord was intact and not broken.A product-specific discrepancy that could have caused or contributed to this observation or to the bands deploying together 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 use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The additional information provided indicated the scope used with this ligator was an olympus gastroscope.Without a model number, the outer diameter of the gastroscope 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 (mbl-6).The knot of the thread [trigger cord] broke.The cap [barrel] loosened and stayed in the patient [barrel detaches from endoscope during use].Additional information from the complaint communication was received on (b)(6) 2018: the mbl-6 cap [barrel] was detached from the endoscope because the knot of the thread broke.There is no information on how the cap was retrieved.Additional information was received on (b)(6) 2018: according to the user, the thread did not break.The knot, near the end of the barrel, was identified as the knot that was released/broken.The device was retrieved with a foreign body forcep.

• 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: 7328654
• MDR Text Key: 102074216
• Report Number: 1037905-2018-00086
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 00827002225534
• UDI-Public: (01)00827002225534(17)180116(10)W3818448
• Combination Product (y/n): N
• Reporter Country Code: SE
• 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: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/09/2018
• Device Age: 13 MO
• Event Location: Hospital
• Date Manufacturer Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2017
• 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
• Treatment: OLYMPUS GASTROSCOPE - UNKNOWN MODEL
• Patient Outcome(s): Required Intervention