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

Catalog Number MBL-U-6

Device Problems Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017); Compatibility Problem (2960)

Patient Problem No Patient Involvement (2645)

Event Date 01/21/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.The device was returned with the barrel still attached to the string with six (6) bands still on the barrel (five (5) black bands and one (1) amber band).The two-way handle, loading catheter, and irrigation adapter were included in the return.An outer diameter of 8.6 mm is the smallest labeled diameter that is acceptable with the device, therefore the barrel was attached to an olympus gif-160 (8.6 mm outer diameter) endoscope and the barrel fit snugly on the endoscope without detaching.The inner diameter of the barrel was inspected and found to be within acceptance criteria.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: a definitive cause for this observation could not be determined because the actual prior to use testing conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.The instructions for use state under system preparation: "attach barrel to tip of endoscope, ensuring barrel is advanced onto tip as far as possible.Note: when placing the barrel onto the distal end of the endoscope, ensure that the trigger cord does not become pinched between the barrel and the endoscope." the instructions for use direct the user to: "lubricate endoscope and exterior portion of barrel." the barrel can dislodge if lubricant is applied to the endoscope prior to attaching the barrel or if lubricant is allowed inside the barrel before the loading process.The instructions for use state: "caution: do not place lubricant inside barrel." a possible contributing factor to barrel detachment includes allowing body fluids to enter the area between the barrel and endoscope.The instructions for use states under precautions: "prior to assembling device, routine endoscopic examination is recommended to confirm diagnosis requiring treatment of esophageal varices or internal hemorrhoids." if the endoscope is wiped free after the initial check for location of the varices, body fluids in this area can be avoided.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 Description

In preparation for a procedure, the user selected a cook 6 shooter saeed multi-band ligator (mbl-u-6).According to the sn [staff nurse], she said that the barrel dislodged from the distal tip of the endoscope (the barrel was too loose and could not fit firmly on the distal tip of the endoscope) [barrel detaches from endoscope].Also, no bands were deployed.The procedure was completed by opening another mbl-u-6 and the procedure was a success.Additional information was received on 01/28/2018: the user did not attempt to deploy the bands outside of the patient.

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.The device was returned with the barrel still attached to the string with six (6) bands still on the barrel (five (5) black bands and one (1) amber band).The two-way handle, loading catheter, and irrigation adapter were included in the return.The barrel was attached to an olympus 2.8 mm channel gif q20 endoscope with an outer diameter of 11 mm and the barrel fit snugly on the endoscope without detaching.The inner diameter of the barrel was inspected and found to be within the acceptance criteria.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: a definitive cause for this observation could not be determined because the actual prior to use testing conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.The instructions for use state under system preparation: "attach barrel to tip of endoscope, ensuring barrel is advanced onto tip as far as possible.Note: when placing the barrel onto the distal end of the endoscope, ensure that the trigger cord does not become pinched between the barrel and the endoscope." the instructions for use direct the user to: "lubricate endoscope and exterior portion of barrel." the barrel can dislodge if lubricant is applied to the endoscope prior to attaching the barrel or if lubricant is allowed inside the barrel before the loading process.The instructions for use state: "caution: do not place lubricant inside barrel." a possible contributing factor to barrel detachment includes allowing body fluids to enter the area between the barrel and endoscope.The instructions for use states under precautions: "prior to assembling device, routine endoscopic examination is recommended to confirm diagnosis requiring treatment of esophageal varices or internal hemorrhoids." if the endoscope is wiped free after the initial check for location of the varices, body fluids in this area can be avoided.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.H3 other text : investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.The device was returned with the barrel still attached to the string with six (6) bands still on the barrel (five (5) black bands and one (1) amber band).The two-way handle, loading catheter, and irrigation adapter were included in the return.The barrel was attached to an olympus 2.8 mm channel gif q20 endoscope with an outer diameter of 11 mm and the barrel fit snugly on the endoscope without detaching.The inner diameter of the barrel was inspected and found to be within the acceptance criteria.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: a definitive cause for this observation could not be determined because the actual prior to use testing conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.The instructions for use state under system preparation: "attach barrel to tip of endoscope, ensuring barrel is advanced onto tip as far as possible.Note: when placing the barrel onto the distal end of the endoscope, ensure that the trigger cord does not become pinched between the barrel and the endoscope." the instructions for use direct the user to: "lubricate endoscope and exterior portion of barrel." the barrel can dislodge if lubricant is applied to the endoscope prior to attaching the barrel or if lubricant is allowed inside the barrel before the loading process.The instructions for use state: "caution: do not place lubricant inside barrel." a possible contributing factor to barrel detachment includes allowing body fluids to enter the area between the barrel and endoscope.The instructions for use states under precautions: "prior to assembling device, routine endoscopic examination is recommended to confirm diagnosis requiring treatment of esophageal varices or internal hemorrhoids." if the endoscope is wiped free after the initial check for location of the varices, body fluids in this area can be avoided.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.

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.The device was returned with the barrel still attached to the string with six (6) bands still on the barrel (five (5) black bands and one (1) amber band).The two-way handle, loading catheter, and irrigation adapter were included in the return.The barrel was attached to an olympus 2.8 mm channel gif q20 endoscope with an outer diameter of 11 mm and the barrel fit snugly on the endoscope without detaching.The inner diameter of the barrel was inspected and found to be within the acceptance criteria.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 endoscope used was an olympus cf-q180al endoscope.Per the device labeling, the mbl-u-6 is compatible with 8.6-11.3 mm endoscope diameters.The outer diameter of the olympus cf-q180al colonoscope is 12.8 mm which is incompatible with the mbl-u-6 device.The use of an incorrect endoscope can result in barrel detachment.This is the most likely cause for the reported observation.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 comments regarding this report: based on the information provided that an incompatible endoscope was used with the device, 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.H3 other text : investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.The device was returned with the barrel still attached to the string with six (6) bands still on the barrel (five (5) black bands and one (1) amber band).The two-way handle, loading catheter, and irrigation adapter were included in the return.The barrel was attached to an olympus 2.8 mm channel gif q20 endoscope with an outer diameter of 11 mm and the barrel fit snugly on the endoscope without detaching.The inner diameter of the barrel was inspected and found to be within the acceptance criteria.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 endoscope used was an olympus cf-q180al endoscope.Per the device labeling, the mbl-u-6 is compatible with 8.6-11.3 mm endoscope diameters.The outer diameter of the olympus cf-q180al colonoscope is 12.8 mm which is incompatible with the mbl-u-6 device.The use of an incorrect endoscope can result in barrel detachment.This is the most likely cause for the reported observation.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 comments regarding this report: based on the information provided that an incompatible endoscope was used with the device, 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
• Type of Device: MND, LIGATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7276873
• MDR Text Key: 100528363
• Report Number: 1037905-2018-00059
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 00827002319172
• UDI-Public: (01)00827002319172(17)180927(10)W3924431
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MBL-U-6
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/21/2018
• Device Age: 4 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS ENDOSCOPE - CF-Q180AL; OLYMPUS ENDOSCOPE - GIF-Q180; OLYMPUS GIF 160 ENDOSCOPE