MAUDE Adverse Event Report: COOK ENDOSCOPY INSTINCT ENDOSCOPIC HEMOCLIP; PKL, LIGATOR, HEMORRHOIDAL

Catalog Number INSC-7-230-S

Device Problem Separation Failure (2547)

Patient Problems Hemostasis (1895); Tissue Damage (2104); No Consequences Or Impact To Patient (2199)

Event Date 10/17/2016

Event Type  Injury  

Manufacturer Narrative

Investigation evaluation: the evaluation of the returned device confirmed the report.As received, the clip could not be opened.Upon forcing the jaws open, the drive wire could then be moved slightly back and forth.However, the movement did not result in any movement of the clip jaws.This is an indication that the hook of the drive wire had pulled through the driver legs and that the clip was in a partially deployed state.As a result of this condition, functional testing could not be performed.However, with an expected amount of force at the handle, the clip completed the deployment process outside of an endoscope.Once the clip was deployed, the distal end components were carefully examined under magnification.No defects or anomalies were observed that could have contributed to the difficulty in deployment observed by the user.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 conclusions: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The instructions for use include the following precaution: "if clip deployment device is used with endoscope in a torqued or retroflexed position, clip deployment difficulties can occur." the instructions for use state: "to permanently deploy clip, pull handle spool toward handle thumb ring until clip detaches.Note: if separation of clip is not immediate, gently move catheter back and forth or use other endoscopic maneuvers to separate catheter from clip." prior to distribution, all instinct endoscopic hemoclips are subjected to a visual inspection and functional testing 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: 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.Investigation evaluation: the evaluation of the returned device confirmed the report.As received, the clip could not be opened.Upon forcing the jaws open, the drive wire could then be moved slightly back and forth.However, the movement did not result in any movement of the clip jaws.This is an indication that the hook of the drive wire had pulled through the driver legs and that the clip was in a partially deployed state.As a result of this condition, functional testing could not be performed.However, with an expected amount of force at the handle, the clip completed the deployment process outside of an endoscope.Once the clip was deployed, the distal end components were carefully examined under magnification.No defects or anomalies were observed that could have contributed to the difficulty in deployment observed by the user.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 conclusions: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The instructions for use include the following precaution: "if clip deployment device is used with endoscope in a torqued or retroflexed position, clip deployment difficulties can occur." the instructions for use state: "to permanently deploy clip, pull handle spool toward handle thumb ring until clip detaches.Note: if separation of clip is not immediate, gently move catheter back and forth or use other endoscopic maneuvers to separate catheter from clip." prior to distribution, all instinct endoscopic hemoclips are subjected to a visual inspection and functional testing 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: 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

During a colonoscopy, the physician used a cook instinct endoscopic hemoclip.As reported to customer relations: "the clip was attached to the targeted site but would not deploy.The clip would not re-open so the physician pulled the clip off the targeted site and removed it.The targeted site looked like it would have initially used two clips, but a greater defect [subsequent bleeding] was made in pulling off the clip so three clips were used to complete the procedure.".

• Brand Name: INSTINCT ENDOSCOPIC HEMOCLIP
• Type of Device: PKL, LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 6098848
• MDR Text Key: 59735152
• Report Number: 1037905-2016-00460
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 00827002183438
• UDI-Public: (01)00827002183438(17)190901(10)W3766905
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: INSC-7-230-S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/17/2016
• Device Age: 1 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/17/2016
• Initial Date FDA Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OLYMPUS CF-190 ENDOSCOPE
• Patient Outcome(s): Required Intervention