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

Model Number	G24654
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Device Handling Problem (3265)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation evaluation: the investigation is on-going; the device was received at the time of this report.A follow-up emdr will be provided.
Event or Problem Description
During an endoscopic variceal ligation (evl), the physician used a cook 6 shooter saeed multi-band ligator.It was reported that the physician was using the mbl-6-ov and the barrel slipped off the scope and had to be retrieved out of the stomach with a net.An unintended section of the device did not remain inside the patient¿s body.The barrel that fell off the end of the scope required the physician to retrieve the barrel from the patients stomach.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence and the procedure was completed with the device in question.
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.Our laboratory evaluation of the product said to be involved could not confirm the report as described.The empty barrel with 2 black deployed and constricted bands stuck to it, the trigger cord, two way handle, loading catheter and the irrigation adapter were included in the return.During a functional test, the barrel was loaded onto the end of an olympus gif-q20 endoscope with an outer diameter of 11.0 mm.The barrel fits snugly on the end of the endoscope without detachment.During a visual examination, the trigger cord was examined and all twelve (12) deployment beads were present.The beads were verified for correct location using bead inspection plate.The beads were examined using magnification and found to be correctly filled and had no evidence of excess flash.The length of the trigger cord was measured between the knots which is within tolerance.The trigger cord was intact and not broken.An evaluation of the handle wheel movement was performed and the wheel functioned as intended.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: the additional information received indicated that the device was being used with an olympus gif-h190 endoscope.Research of the endoscope found that the distal end of an olympus gif-h190 scope is 9.2 mm which is smaller than the minimum recommended endoscope diameter of the device.The mbl-6-ov device is recommended for use with endoscopes with a distal end diameter of 9.5 - 11.5 mm.As indicated on the product label.Use of this device with an incompatible endoscope is the most likely cause of the reported issue.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 note: based on the information provided, the device was used with an incompatible olympus endoscope.A cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

• 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: 12593192
• Report Number: 1037905-2021-00558
• Device Sequence Number: 4523044
• Product Code: MND
• UDI-Device Identifier: 00827002246546
• UDI-Public: (01)00827002246546(17)211222(10)W4419777
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/22/2021
• Device Model Number: G24654
• Device Catalogue Number: MBL-6-OV
• Device Lot Number: W4419777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 11/01/2021
• 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: ENDOSCOPE-OLYMPUS GIF-H190
• Outcome Attributed to Adverse Event: Required Intervention