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

Model Number	G24748
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	09/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During preparation for an esophageal varices ligation, the physician prepared to use a cook 6 shooter saeed multi-band ligator.It was reported that when the physician opened the package, he realized that the ligator cord looked strange, so he didn't use it.Images provided show that the trigger cord is not properly retained under the bands causing bands to not deploy or difficulty to deploy.As it was discovered 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 the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was performed only by the pictures provided with this report because the products said to be involved were not provided to cook for evaluation.The lot number was provided in one of the photos and matches this report.The label in the photo matches the product reported.Review of the device photo received confirmed the complaint.The photo shows the barrel with all 6 bands remaining on it with one leg of the trigger cord extended out from the barrel and not in place under the bands.3 deployment beads can be seen on the exposed leg of the trigger cord.No other details can be determined from the picture.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.
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in an open box from the lot number provided in the report.The label matches the product returned.The handle and the loading catheter were not included in the return.Two photos were also provided by the customer.The lot number was provided in one of the photos and matches this report.The label in the photo matches the product reported.Review of the photo of the device confirmed the complaint.The photo shows the barrel with all 6 bands remaining on it with one leg of the trigger cord extended out from the barrel and not in place under the bands.Three deployment beads can be seen on the exposed leg of the trigger cord.No other details can be determined from the picture.Our laboratory evaluation of the product returned also confirmed the complaint.A visual inspection of the barrel returned found that all 6 bands were remaining on it with one leg of the trigger cord extended out from the barrel and not in place under the bands.Three deployment beads can be seen on the exposed leg of the trigger cord.The remaining nine deployment beads were still on the barrel but slightly shifted out of place.The length of the trigger cord was measured within the tolerance.The trigger cord was not broken.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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: a definitive cause for this observation could not be determined because the actual prior to use testing conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.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.

• 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: 15551125
• Report Number: 1037905-2022-00549
• Device Sequence Number: 6180336
• Product Code: MND
• UDI-Device Identifier: 00827002247482
• UDI-Public: (01)00827002247482(17)230203(10)W4561944
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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: 02/03/2023
• Device Model Number: G24748
• Device Catalogue Number: MBL-6-I
• Device Lot Number: W4561944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 11/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2022
• 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: OLYMPUS GASTROSCOPE 160 SERIES
• Patient Sex: Unknown