MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC 6 SHOOTER SAEED MULTI-BAND LIGATOR; MND, LIGATOR

Model Number	G24748
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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: a corrective action has been initiated to reduce occurrences of the mbl bands not tight enough to function appropriately.The product said to be involved is included in the scope of the corrective actions.Inadequate storage conditions can contribute to the properties exhibited as described in the customer complaint.The instructions for use advise the user to: "store in a dry location, away from temperature extremes." 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.A corrective action has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to the implementation of this corrective action.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
During an esophageal variceal ligation, the physician used a cook 6 shooter saeed multi-band ligator.It was reported that when the bands are released, some grab and others do not hold the varice, leaving it loose.Other than the deployed bands, a section of the device did not remain in the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in an open box/tray from the lot number provided in the report.The label matches the product returned.The loading catheter, irrigation adapter, and two-way handle were all included in the return.Our laboratory evaluation of the product said to be involved could not confirm the complaint as described.One barrel with 5 bands were returned with 1 loose band in the tray.The 2nd barrel was not returned.As they indicated the barrel was unused it is assumed this the detached band occurred during transit.The remaining 5 bands on the barrel were functionally tested.The multi-band ligator device was attached to an endoscope that was placed in a simulated gastrointestinal position with vacuum attached.The endoscope has an accessory channel that is 2.8 mm in diameter (olympus 2.8 gif q20 endoscope).The multi-band ligator barrel was attached onto the end of the endoscope.The distal end of the endoscope with the barrel attached was placed in a water bath of 37 degrees celsius to simulate body temperature.Simulated varices were placed at the end of the barrel and vacuum pulled and each band was fired while submerged in the water bath.It was observed that the bands constricted and functioned as intended.A visual examination of the device was performed.The trigger cord was examined and all twelve deployment beads were present.The beads were verified for correct location.The beads were examined using magnification and found to be correctly filled and had no evidence of excess flash.The length of the trigger cord was measured between the knots and was within the tolerance.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: our visual and functional evaluation of the returned device was unable to confirm the report.The bands deployed and constricted as expected.A definitive cause for the reported observation could not be determined.Inadequate storage conditions can contribute to the properties exhibited as described in the customer complaint.The instructions for use advise the user to: "store in a dry location, away from temperature extremes." 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.

• Brand Name: 6 SHOOTER SAEED MULTI-BAND LIGATOR
• Common Device Name: MND, LIGATOR
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 17013141
• Report Number: 1037905-2023-00257
• Device Sequence Number: 17874647
• Product Code: MND
• UDI-Device Identifier: 00827002247482
• UDI-Public: (01)00827002247482(17)231011(10)W4644498
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

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: 10/11/2023
• Device Model Number: G24748
• Device Catalogue Number: MBL-6-I
• Device Lot Number: W4644498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCOPE, UNKNOWN MAKE AND MODEL
• Patient Sex: Male