MAUDE Adverse Event Report: COOK ENDOSCOPY 6 SHOOTER SAEED MULTI-BAND LIGATOR; MND, LIGATOR, ESOPHAGEAL

Model Number	G26861
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter section: occupation - unknown.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.A possible contributing factor to premature band deployment includes allowing the trigger cord to become lodged between the barrel and the distal end of the endoscope.This can restrict trigger cord movement and result in premature band deployment if enough tension is applied to pull the cord free.Premature band deployment can also occur if the handle is placed in the firing position before the endoscope is in place inside the patient or even while winding the trigger cord.The user is advised not to apply tension to the trigger cord while winding it on the handle to avoid premature deployment of bands.The instructions for use caution the user: ¿with handle in two-way position, slowly rotate handle clockwise to wind trigger cord onto handle spool until it is taut.Note: care must be taken to avoid deploying a band while winding trigger cord." rapid rotation of the ligator handle can contribute to premature band deployment.The instructions for use direct the user: ¿maintain suction and deploy band by rotating handle clockwise until band release is felt, indicating deployment." 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.
Event or Problem Description
During an endoscopic variceal ligation (evl), the physician used a cook 6 shooter saeed multi-band ligator.The bands failed to deploy.Suction was applied to the varices and the bands slipped from the barrel [prematurely deployed] and did not hold the varices.Other than the deployed bands, 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.
Additional Manufacturer Narrative
Initial reporter section: occupation- unknown.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report based on the 5 bands that had already been deployed and were included in the return.During our laboratory analysis, a visual examination of the devices was performed.The 2 trigger cords were examined and all twelve (12) deployment beads of each cord were present.The beads were examined using magnification and found to be correctly filled and had no evidence of excess flash.The length of each the trigger cord was measured.Trigger cord 1 was measured between the knots and trigger cord 2 measured between the knots.Both of the trigger cord measurements were within the tolerance.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 the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation.No bands remained on the barrels.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.A possible contributing factor to premature band deployment includes allowing the trigger cord to become lodged between the barrel and the distal end of the endoscope.This can restrict trigger cord movement and result in premature band deployment if enough tension is applied to pull the cord free.Premature band deployment can also occur if the handle is placed in the firing position before the endoscope is in place inside the patient or even while winding the trigger cord.The user is advised not to apply tension to the trigger cord while winding it on the handle to avoid premature deployment of bands.The instructions for use caution the user: ¿with handle in two-way position, slowly rotate handle clockwise to wind trigger cord onto handle spool until it is taut.Note: care must be taken to avoid deploying a band while winding trigger cord." rapid rotation of the ligator handle can contribute to premature band deployment.The instructions for use direct the user: ¿maintain suction and deploy band by rotating handle clockwise until band release is felt, indicating deployment." 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, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 11542369
• Report Number: 1037905-2021-00119
• Device Sequence Number: 11745330
• Product Code: MND
• UDI-Device Identifier: 00827002268616
• UDI-Public: (01)00827002268616(17)210512(10)W4346879
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2021

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: 05/12/2021
• Device Model Number: G26861
• Device Catalogue Number: MBL-6-I-5B-S
• Device Lot Number: W4346879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS 170 SERIES ENDOSCOPE; OLYMPUS 170 SERIES ENDOSCOPE.