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

Catalog Number MBL-6

Device Problems Positioning Failure (1158); Nonstandard Device (1420); Failure to Fire (2610)

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

Event Date 08/17/2023

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

In preparation for an esophageal ligation procedure, the physician prepared to use a cook 6 shooter saeed multi-band ligator.It was reported that the handle was stuck so the physician could not switch the position.He removed the device right away.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 clear plastic bag with a blue pouch.No lot number was returned with the device.The loading catheter, handle, and trigger cord were included in the return, however, the barrel with the bands and irrigation adapter did not return.A photo was provided and reviewed.The photo shows the blue pouch with the handle, trigger cord, and loading catheter.Our evaluation of the product said to be involved confirmed the report.The roller clutch is not seated flush into the handle base, causing the handle not to function properly; it stays in the two-way position and will not engage into the firing position.The device was returned to the supplier for further evaluation and the following was provided "during assembly operation that press fits bearing into molded part, bearing was not fully pressed into part.This was not detected during subsequent manufacturing/ inspection operations." 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 laboratory evaluation of the returned device confirmed the complaint.The supplier provided the following, "the root cause was that the bearing was not fully pressed into the molded part." corrective action: inspection camera added to assembly station to detect failure condition (bearing not fully pressed into part) which prevents non-conforming part from passing through work station.Verification: verified assembly equipment identifies and fails non-conforming part (bearing not fully pressed into molded part).Prevention: we've completed a small doe on the molded base part, to determine what we can do process-wise to work the hole size for the bearing closer to nominal.I have also requested max-inscribed/ circularity inspection on the bottom of the hole, to determine if it is less about diameter and more about ovality of a hole (this impacts the press fit in assembly).That inspection is underway." prior to distribution, all 6 shooter saeed multi-band ligators are subjected to a visual inspection to ensure device integrity.Corrective action: a review of the complaint history was conducted and this represents an isolated 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: 17718612
• MDR Text Key: 323048302
• Report Number: 1037905-2023-00430
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 00827002225534
• UDI-Public: (01)00827002225534(17)240320(10)W4710998
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2024
• Device Catalogue Number: MBL-6
• Device Lot Number: W4710998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2023
• 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
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 62 KG