MAUDE Adverse Event Report: COOK ENDOSCOPY 10 SHOOTER SAEED MULTI-BAND LIGATOR; MND, LIGATOR, ESOPHAGEAL

Model Number	G22614
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Death (1802)
Date of Event	01/26/2018
Type of Reportable Event	Death
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.One (1) video was provided of the product from the same lot to aid the investigation.An evaluation of the video provided by the user could not confirm the report.The video provided showed the deployment of nine (9) out of ten (10) bands on a tabletop.All nine (9) bands deployed and constricted as intended.Without return of the complaint device, a complete evaluation could not be performed.The band lot number associated with this complaint was researched and it can be concluded that the bands were within the acceptable date range.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.The information provided indicates that there was a relapse of bleeding.In an event of a relapse of bleeding, the instructions for use advise the user: ¿repeat ligation process as needed.Note: more than one ligation band for each varix may be required to control acute bleeding.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.¿ inadequate storage conditions (excessive light and heat) or sterilization could contribute to the properties exhibited as described in the customer complaint.The band lot number associated with this complaint was researched and it can be concluded that the bands were within the acceptable date range.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 currently being assessed 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 10 shooter saeed multi-band ligator (mbl-10).In the process of using the mbl-10, during the operation, it was noticed that the ring [band] shrunk slowly.There was no reportable information at this time.Additional information was received on (b)(6) 2018: after ligation, two (2) patients had relapses of bleeding and we did not find the bands during revision (subject of this report and see related mdr 1037905-2018-00080).Then we performed a control gastroscopy and a blakemore sonde [tube] was placed.Additional information was received on (b)(6) 2018: control gastroscopy was performed in both events with the two (2) patients.They had strong bleeding and there was no choice, the physician had to make a control diagnostic.For both events, with patients, it was caused by low-quality band ligation systems (bands fell off the site prematurely and caused a relapse of bleeding).There was nothing to do except for control gastroenterology and the blakemore tube placements, because the ligations did not work properly.Both patients passed away at that moment (one during placement and another one right after it) (subject of this report and see related mdr 1037905-2018-00080).
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.One (1) video was provided of the product from the same lot to aid the investigation.An evaluation of the video provided by the user could not confirm the report.The video provided showed the deployment of nine (9) out of ten (10) bands on a tabletop.All nine (9) bands deployed and constricted as intended.Without return of the complaint device, a complete evaluation could not be performed.The band lot number associated with this complaint was researched and it can be concluded that the bands were within the acceptable date range.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.The information provided indicates that there was a relapse of bleeding.In an event of a relapse of bleeding, the instructions for use advise the user: ¿repeat ligation process as needed.Note: more than one ligation band for each varix may be required to control acute bleeding.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.¿ inadequate storage conditions (excessive light and heat) or sterilization could contribute to the properties exhibited as described in the customer complaint.The band lot number associated with this complaint was researched and it can be concluded that the bands were within the acceptable date range.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
The following was initially provided on 03/05/2018: "during an endoscopic variceal ligation (evl), the physician used a cook 10 shooter saeed multi-band ligator (mbl-10).In the process of using the mbl-10, during the operation, it was noticed that the ring [band] shrunk slowly.There was no reportable information at this time.Additional information was received on 02/08/2018: after ligation, two (2) patients had relapses of bleeding and we did not find the bands during revision (subject of this report and see related mdr 1037905-2018-00080).Then we performed a control gastroscopy and a blakemore sonde [tube] was placed.Additional information was received on 02/15/2018: control gastroscopy was performed in both events with the two (2) patients.They had strong bleeding and there was no choice, the physician had to make a control diagnostic.For both events, with patients, it was caused by low-quality band ligation systems (bands fell off the site prematurely and caused a relapse of bleeding).There was nothing to do except for control gastroenterology and the blakemore tube placements, because the ligations did not work properly.Both patients passed away at that moment (one during placement and another one right after it) (subject of this report and see related mdr 1037905-2018-00080)." additional information was received on 04/04/2018 from the distributor: we just received an answer from our doctor according to the issues with the problem of unsuccessful ligations.He [the physician] is not ready to give you any further information about his patients and their conditions before and after ligation procedures, especially autopsy and all the information and documents related to this situation in general, according to russian law (subject of this report and see related mdr 1037905-2018-00080).He also said the storage conditions were followed as it was described in your instructions inside of the package of the products.
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.One (1) video was provided of the product from the same lot to aid the investigation.An evaluation of the video provided by the user could not confirm the report.The video provided showed the deployment of nine (9) out of ten (10) bands on a tabletop.All nine (9) bands deployed and constricted as intended.Without return of the complaint device, a complete evaluation could not be performed.The band lot number associated with this complaint was researched and it can be concluded that the bands were within the acceptable date range.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.The information provided indicates that there was a relapse of bleeding.In an event of a relapse of bleeding, the instructions for use advise the user: ¿repeat ligation process as needed.Note: more than one ligation band for each varix may be required to control acute bleeding.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.¿ inadequate storage conditions (excessive light and heat) or sterilization could contribute to the properties exhibited as described in the customer complaint.The band lot number associated with this complaint was researched and it can be concluded that the bands were within the acceptable date range.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 currently being assessed and a follow up report will be sent.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
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.One (1) video was provided of the product from the same lot to aid the investigation.An evaluation of the video provided by the user could not confirm the report.The video provided showed the deployment of nine (9) out of ten (10) bands on a tabletop.All nine (9) bands deployed and constricted as intended.Without return of the complaint device, a complete evaluation could not be performed.The band lot number associated with this complaint was researched and it can be concluded that the bands were within the acceptable date range.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.The information provided indicates that there was a relapse of bleeding.In an event of a relapse of bleeding, the instructions for use advise the user: ¿repeat ligation process as needed.Note: more than one ligation band for each varix may be required to control acute bleeding.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.¿ inadequate storage conditions (excessive light and heat) or sterilization could contribute to the properties exhibited as described in the customer complaint.The band lot number associated with this complaint was researched and it can be concluded that the bands were within the acceptable date range.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
The following was initially provided on 03/05/2018: "during an endoscopic variceal ligation (evl), the physician used a cook 10 shooter saeed multi-band ligator (mbl-10).In the process of using the mbl-10, during the operation, it was noticed that the ring (band) shrunk slowly.There was no reportable information at this time.Additional information was received on 02/08/2018: after ligation, two (2) patients had relapses of bleeding and we did not find the bands during revision (subject of this report and see related mdr 1037905-2018-00080).Then we performed a control gastroscopy and a blakemore sonde (tube) was placed.Additional information was received on 02/15/2018: control gastroscopy was performed in both events with the two (2) patients.They had strong bleeding and there was no choice, the physician had to make a control diagnostic.For both events, with patients, it was caused by low-quality band ligation systems (bands fell off the site prematurely and caused a relapse of bleeding).There was nothing to do except for control gastroenterology and the blakemore tube placements, because the ligations did not work properly.Both patients passed away at that moment (one during placement and another one right after it) (subject of this report and see related mdr 1037905-2018-00080)." additional information was received on 04/04/2018 from the distributor: we just received an answer from our doctor according to the issues with the problem of unsuccessful ligations.He (the physician) is not ready to give you any further information about his patients and their conditions before and after ligation procedures, especially autopsy and all the information and documents related to this situation in general, according to russian law (subject of this report and see related mdr 1037905-2018-00080).He also said the storage conditions were followed as it was described in your instructions inside of the package of the products.Other than the deployed bands, a section of the device did not remain in the patient¿s body.The patient experienced re-bleeding and required a control gastroscopy and blakemore tube insertion due to this occurrence.According to the initial reporter, the patient passed away.

• Brand Name: 10 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: 7314947
• Report Number: 1037905-2018-00081
• Device Sequence Number: 2248793
• Product Code: MND
• UDI-Device Identifier: 00827002226142
• UDI-Public: (01)00827002226142(17)180515(10)W3866486
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/04/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: G22614
• Device Catalogue Number: MBL-10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/26/2018
• Device Age: 8 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/08/2018
• Supplement Date Received by Manufacturer: 03/01/2018; 04/04/2018; 05/07/2018; 06/04/2018
• Initial Report FDA Received Date: 03/05/2018
• Supplement Report FDA Received Date: 03/26/2018; 04/27/2018; 06/04/2018; 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Life Threatening; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 80