MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC 4 SHOOTER SAEED MULTI-BAND LIGATOR; MND, LIGATOR

Model Number	G22613
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
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 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.The mbl-4 requires a scope outer diameter size of 9.5 mm - 13 mm.The labeling on the device lists the recommended endoscope size for each reference part number (rpn).Use of the product with an endoscope too large or too small can result in the barrel becoming dislodged.The user was unable to specify the scope model used to confirm the correct size was used.The instructions for use state under system preparation: "attach barrel to tip of endoscope, ensuring barrel is advanced onto tip as far as possible.Note: when placing the barrel onto the distal end of the endoscope, ensure that the trigger cord does not become pinched between the barrel and the endoscope." the instructions for use direct the user to: "lubricate endoscope and exterior portion of barrel." the barrel can dislodge if lubricant is applied to the endoscope prior to attaching the barrel or if lubricant is allowed inside the barrel before the loading process.The instructions for use state: "caution: do not place lubricant inside barrel." a possible contributing factor to barrel detachment includes allowing body fluids to enter the area between the barrel and endoscope.The instructions for use state under precautions: "prior to assembling device, routine endoscopic examination is recommended to confirm diagnosis requiring treatment of esophageal varices or internal hemorrhoids." if the endoscope is wiped free after the initial check for location of the varices, body fluids in this area can be avoided.Prior to distribution, all 4 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.
Event or Problem Description
During an esophageal variceal ligation, the physician used a cook 4 shooter saeed multi-band ligator.It was reported that the [barrel] fell-off and into the patient before the device could be used.The barrel was retrieved from the patient's stomach.Attempts have been made to get clarification regarding how the barrel was retrieved, however, it was reported that there were no adverse effects on the patient 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 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.The instructions for use state under system preparation: "attach barrel to tip of endoscope, ensuring barrel is advanced onto tip as far as possible.Note: when placing the barrel onto the distal end of the endoscope, ensure that the trigger cord does not become pinched between the barrel and the endoscope." the instructions for use also direct the user to: "lubricate endoscope and exterior portion of barrel." the barrel can dislodge if lubricant is applied to the endoscope prior to attaching the barrel or if lubricant is allowed inside the barrel before the loading process.The instructions for use state: "caution: do not place lubricant inside barrel." a possible contributing factor to barrel detachment includes allowing body fluids to enter the area between the barrel and endoscope.The instructions for use state under precautions: "prior to assembling device, routine endoscopic examination is recommended to confirm diagnosis requiring treatment of esophageal varices or internal hemorrhoids." if the endoscope is wiped free after the initial check for location of the varices, body fluids in this area can be avoided.Prior to distribution, all 4 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: 4 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: 16725964
• Report Number: 1037905-2023-00171
• Device Sequence Number: 7967282
• Product Code: MND
• UDI-Device Identifier: 00827002226135
• UDI-Public: (01)00827002226135(17)231012(10)W4645075
• 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,Followup
• Report Date (Section B): 05/22/2023

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: 10/12/2023
• Device Model Number: G22613
• Device Catalogue Number: MBL-4
• Device Lot Number: W4645075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2022
• 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: PENTAX EG29-I10 GASTROSCOPE; PENTAX SCOPE-UNKNOWN MODEL
• Patient Sex: Unknown