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

Model Number G22692

Device Problems Failure to Fire (2610); Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This investigation is ongoing.A follow-up emdr will be submitted within 30 days of submission of this report.

Event Description

During an esophageal variceal ligation (evl), the physician used a cook 6 shooter saeed multi-band ligator.It was reported that the user installed the device but discovered that the handle could not be rotated as expected.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.

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in a white plastic bag.Only the handle was received as a return.No product labeling was provided with the return and the lot number could not be confirmed.A video was also provided and reviewed.The video provided shows the device handle being pushed with the users thumb but the handle wheel will not turn.Our laboratory evaluation of the product said to be involved confirmed the report.The two-way handle was returned in the firing position, with handle manipulation it would only rotate in the counterclockwise direction and would not rotate in the clockwise direction.The correct functionality of the handle would be rotation in the clockwise direction while in the firing position.The device was returned to the supplier for further evaluation.The supplier provided the following information: "during disassembly of the returned sample, it was discovered that the bearing placement was in the part incorrectly (backwards)." 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: the functional verification of the returned handle confirmed the report.The handle would only rotate in the counterclockwise direction in the firing position which is not the correct rotational direction.The handle supplier's investigation determined the handle was assembled incorrectly during manufacturing.The supplier implemented a process change which addresses the incorrect assembly and increased the verification level for correct rotation.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 and this represents an unusual occurrence.The likelihood of occurrence is considered remote.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
• Type of Device: 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: 16487279
• MDR Text Key: 310803726
• Report Number: 1037905-2023-00109
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 00827002226920
• UDI-Public: (01)00827002226920(17)230922(10)W4638846
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2023
• Device Model Number: G22692
• Device Catalogue Number: MBL-6-F
• Device Lot Number: W4638846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2022
• 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: SCOPE UNKNOWN MAKE AND MODEL.