MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC 10 SHOOTER SAEED MULTI-BAND LIGATOR; MND, LIGATOR

Catalog Number	MBL-10
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an unspecified ligation procedure, the physician used a cook 10 shooter saeed multi-band ligator.It was reported that the knot on the twine was "much larger and as a result when pulling the threads through, the blue piece came off of the white plastic threader' [blue hook detaches].As a result, the procedure time was extended and we had to administer additional sedation to the patient.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.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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 subassembly history record for the loading catheter said to be involved was reviewed.The quality control tensile test performed on a sample of the manufactured units met the acceptance criteria.A discrepancy or anomaly was not observed with the product that was released for distribution.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.If the knot and the hook are placed closer than 2 cm, this can create resistance when withdrawing the loading catheter through the ligator handle and/or accessory channel of the endoscope.The instructions for use state: ¿attach trigger cord to hook on end of loading catheter, leaving approximately 2 cm of trigger cord between knot and hook.Withdraw loading catheter and trigger cord up through endoscope and out through handle." if additional pressure is applied to the loading catheter when resistance is encountered, this could contribute to separation of the blue hook from the loading catheter.The reported observation can occur if the blue hook gets caught in the accessory channel of the endoscope.The instructions for use advise the user: "it is vital that the integrity of the working channel is intact." prior to distribution, all 6 shooter saeed multi-band ligators are subjected to a visual inspection to ensure device integrity.All loading catheters that are included in the multi-band ligators are subjected to a visual inspection and functional testing 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: 10 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: 17837264
• Report Number: 1037905-2023-00468
• Device Sequence Number: 7409433
• Product Code: MND
• UDI-Device Identifier: 00827002226142
• UDI-Public: (01)00827002226142(17)240707(10)W4743568
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 09/28/2023

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: 07/07/2024
• Device Catalogue Number: MBL-10
• Device Lot Number: W4743568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2023
• 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