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

Model Number	G25424
Medical Device Problem Codes	Failure to Fire (2610); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
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.However, a photo of the product box label was received confirming the lot number.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.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 ligation procedure, the physician prepared to use a cook 6 shooter saeed multi-band ligator.It was reported that the threads were twisted and could not be used [leads to difficulty deploy bands].As the observation was made prior to patient contact, a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence, and according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
This file was originally assessed as reportable for the threads being twisted prior to use [leading to difficulty deploying bands].The device was received on 07/05/2023 and our evaluation of the returned device was unable to confirm the report.Upon investigation, it was determined that all 6 bands were on the barrel and the trigger cord was present, retained under the bands and the deployment beads were in the correct position.There was no evidence of the threads being twisted.There was no evidence of any discrepancy or anomaly that would have led to the bands being difficult or unable to deploy.Therefore, this is no longer a emdr reportable malfunction as this observation has not historically caused or contributed to a serious injury nor death.
Event or Problem Description
This correction follow up report is being submitted to cancel the initial report submitted relating to this event.Reference the h10 additional information section for this justification.

• 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: 16701626
• Report Number: 1037905-2023-00164
• Device Sequence Number: 3677222
• Product Code: MND
• UDI-Device Identifier: 00827002254244
• UDI-Public: (01)00827002254244(17)230613(10)W4604748
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2023

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: 06/13/2023
• Device Model Number: G25424
• Device Catalogue Number: MBL-6
• Device Lot Number: W4604748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 04/10/2023; 04/10/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 05/02/2023; 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2022
• 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: Unknown