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

Catalog Number	MBL-6-F-I
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	02/15/2016
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.Premature band deployment can occur if care is not exercised while loading the device onto the endoscope.The instructions for use direct the user to "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." premature band deployment can also occur if the handle is placed in the firing position before the endoscope is in place inside the patient.The instructions for use direct the user "with handle in two-way position, introduce endoscope into esophagus.After intubation, place handle in firing position." rapid rotation of the ligator handle can contribute to premature band deployment.The instructions for use direct the user to "maintain suction and deploy band by rotating handle clockwise until band release is felt, indicating deployment." during the procedure, endoscopic suction is applied to the banding site to properly place a ligator band.Premature band deployment can also occur if the handle is rotated before maintaining suction on the banding site.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 esophageal variceal ligation procedure, the physician used a cook 6 shooter saeed multi-band ligator.As reported to customer relations: "during the procedure the doctor reported the release of three leagues [bands] at one go, after the shooting [premature deployment].".
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.Premature band deployment can occur if care is not exercised while loading the device onto the endoscope.The instructions for use direct the user to "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." premature band deployment can also occur if the handle is placed in the firing position before the endoscope is in place inside the patient.The instructions for use direct the user "with handle in two-way position, introduce endoscope into esophagus.After intubation, place handle in firing position." rapid rotation of the ligator handle can contribute to premature band deployment.The instructions for use direct the user to "maintain suction and deploy band by rotating handle clockwise until band release is felt, indicating deployment." during the procedure, endoscopic suction is applied to the banding site to properly place a ligator band.Premature band deployment can also occur if the handle is rotated before maintaining suction on the banding site.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
On (b)(6) 2016, the following was reported to the cook: during an esophageal variceal ligation procedure, the physician used a cook 6 shooter saeed multi-band ligator.As reported to customer relations: "during the procedure the doctor reported the release of three leagues [bands] at one go, after the shooting [premature deployment]." on 09/09/16, we received the endoscope make used during the procedure.

• 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: 5778670
• Report Number: 1037905-2016-00235
• Device Sequence Number: 56611
• Product Code: MND
• UDI-Device Identifier: 00827002252400
• UDI-Public: (01)00827002252400(17)160209(10)W3535962
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2016

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 Catalogue Number: MBL-6-F-I
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 1 YR
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2016
• Supplement Report FDA Received Date: 09/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR