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

Catalog Number MBL-6-OV

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Event Description

During an unspecified ligation procedure, the physician used a cook 6 shooter saeed multi-band ligator.It was reported that the device had 7 total bands loaded on the barrel.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: 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.A review of the device history record could not be conducted because the lot number was not provided.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.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: 16416315
• MDR Text Key: 309951962
• Report Number: 1037905-2023-00082
• Device Sequence Number: 1
• Product Code: MND
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MBL-6-OV
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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