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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Gastrointestinal Hemorrhage (4476)
Date of Event	06/09/2020
Type of Reportable Event	Serious Injury
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.A review of the associated raw material lots for the bands was performed.A review of the inspection records found the bands conforming.A review of similar complaints was performed.No other complaints were received for the finished device lot.The overall complaint trend was evaluated for similar complaints prior to this occurrence and no trend was identified.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.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 selected a cook 6 shooter saeed multi-band ligator.Post procedure, the patient experienced major hemorrhages when pressure ulcers fell off after iv ligation.The patient had to be hospitalized in intensive care for an extended stay.Additional information received on 22-jul-2020 stated: they didn¿t change medical treatment (anticoagulation¿) for patient.They will try with another device (mbl-u-6) and let us know if new incidents occurs.A section of the device did not remain in the patient's body.According to the initial reporter, the patient experienced major hemorrhages.The patient was hospitalized in intensive care for an extended stay.
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.A review of the associated raw material lots for the bands was performed.A review of the inspection records found the bands conforming.A review of similar complaints was performed.No other complaints were received for the finished device lot.The overall complaint trend was evaluated for similar complaints prior to this occurrence and no trend was identified.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.Additional information received indicated that the device functioned as intended in that it deployed onto the varices and constricted in such a way to allow the tissue to necrose and fall off.Rebleeding is a known complication of esophageal variceal ligation (evl) and is affected by many clinical factors such as the severity of the varices and the underlying disease progression.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 selected a cook 6 shooter saeed multi-band ligator.Post procedure, the patient experienced major hemorrhages when pressure ulcers fell off after iv ligation.The patient had to be hospitalized in intensive care for an extended stay.Additional information received on 22-july-2020 stated: they didn¿t change medical treatment (anticoagulation) for the patient.Additional information received on 27-august-2020 stated: this is not a band slip off [band did not slip off varix], as the event occurred several days after delivery.The doctor explained that hemorrhages occurred when the varix was occluded and necrosed due to the band.The normal pathway at this stage is that the varix and band fall spontaneously.In this case, when the band and the necrosed varix fell from the esophagus, the healing was not done and the patient bled.Other than the deployed bands, a section of the device did not remain in the patient's body.According to the initial reporter, the patient experienced major hemorrhages.The patient was hospitalized in intensive care for an extended stay.
Event or Problem Description
The following was reported previously "during an endoscopic variceal ligation (evl), the physician selected a cook 6 shooter saeed multi-band ligator.Post procedure, the patient experienced major hemorrhages when pressure ulcers fell off after iv ligation.The patient had to be hospitalized in intensive care for an extended stay.Additional information received on 22-july-2020 stated: they didn't change medical treatment (anticoagulation) for the patient.Additional information received on 27-august-2020 stated: this is not a band slip off [band did not slip off varix], as the event occurred several days after delivery.The doctor explained that hemorrhages occurred when the varix was occluded and necrosed due to the band.The normal pathway at this stage is that the varix and band fall spontaneously.In this case, when the band and the necrosed varix fell from the esophagus, the healing was not done and the patient bled.Other than the deployed bands, a section of the device did not remain in the patient's body.According to the initial reporter, the patient experienced major hemorrhages.The patient was hospitalized in intensive care for an extended stay.On (b)(6) 2021, a meeting was conducted with the area representative and the division sales manager about this event and other similar events reported (mdr reference numbers 1037905-2020-00292, 1037905-2020-00295, 1037905-2020-00296, 1037905-2020-00297, 1037905-2020-00313, 1037905-2020-00314, 1037905-2020-00314, 1037905-2020-00317, 1037905-2020-00316, 1037905-2021-00043,1037905-2021-00123).The information indicated that the devices functioned as intended and there are no clinical explanations as to why the bleeding happened.
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.As the user reported several instances of patient rebleeding occurring on multiple patients and across a variety of device lot numbers the following was investigated: -a review of the associated raw material lots for the bands was performed.For the lots reported, multiple lots were used and a review of the inspection records found the bands conforming.-a review of similar complaints was performed.No other complaints were received for these finished device lots.-the overall complaint trend was evaluated for similar complaints prior to this occurrence and no trend was identified.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.Additional information received indicated that the device functioned as intended in that it deployed onto the varices and constricted in such a way to allow the tissue to necrose and fall off.Rebleeding is a known complication of esophageal variceal ligation (evl) and is affected by many clinical factors such as the severity of the varices and the underlying disease progression.The ligation process may also need to be repeated.The instructions for use states: "note: more than one ligation band for each varix may be required to control acute bleeding." in addition, the user is further instructed "if more bands are required, remove endoscope and attach a new device.Note: an average of 3 to 4 ligation sessions may be required to obliterate varices." 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: 10387918
• Report Number: 1037905-2020-00313
• Device Sequence Number: 11231561
• Product Code: MND
• UDI-Device Identifier: 00827002246546
• UDI-Public: (01)00827002246546(17)210106(10)W4304412
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2021

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: 01/06/2021
• Device Model Number: G24654
• Device Catalogue Number: MBL-6-OV
• Device Lot Number: W4304412
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 08/27/2020; 03/08/2021
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 09/17/2020; 04/01/2021
• 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: OLYMPUS H-190
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 66 YR