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

Model Number	G25240
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter occupation: unknown.Investigation evaluation: the report was confirmed by the picture provided as four of the five deployed bands seen laying on the plastic tray had not constricted.Three black bands and one amber band were not constricted in the photo.One black band in the photo appeared to have constricted as normal.No further evaluation can be performed without the product being returned.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 complaint product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.Inadequate storage conditions contribute to the properties exhibited as described in the customer complaint.The instructions for use advise the user to: "store in a dry location, away from temperature extremes." prior to distribution, all 6 shooter saeed multi-band ligators are subjected to a visual inspection to ensure device integrity.A review of the nonconformances documented for the lot number said to be involved was performed and confirmed that this lot met 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 digestive endoscopy with ligation of esophageal varices procedure, the physician used a cook 6 shooter saeed multi-band ligator.The elastic ligation kit bands did not shrink, were hardened, strangling the varicose veins, and could not perform the procedure.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.

• 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: 10922754
• Report Number: 1037905-2020-00515
• Device Sequence Number: 4295089
• Product Code: MND
• UDI-Device Identifier: 00827002252400
• UDI-Public: (01)00827002252400(17)201029(10)W4279602
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 11/30/2020

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: 10/29/2020
• Device Model Number: G25240
• Device Catalogue Number: MBL-6-F-I
• Device Lot Number: W4279602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR