MAUDE Adverse Event Report: COOK ENDOSCOPY INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE; PKL, LIGATOR, HEMORRHOIDAL

Model Number G58010

Device Problems Unintended System Motion (1430); Difficult to Open or Close (2921); Premature Separation (4045)

Patient Problem Gastrointestinal Hemorrhage (4476)

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k192697.A follow-up emdr will be provided upon completion of the investigation.

Event Description

During an endoscopic procedure, the physician used a cook instinct plus endoscopic clipping device.Once the clip was visible on the endoview, the physician asked her to open the clip.She noted that, when she tried to open the clip, the clip did not open but the clip detached from the catheter in the closed positions and stayed attached to the drive wire.The drive wire pushed the closed clip into the lesion.Once the closed clip made contact with the ulcer, it caused more bleeding.They then removed the clip.The clip remained inside the patient¿s body to pass naturally.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Pma/510(k) # k192697 investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described, because all the device components (particularly the clip) were not included in the return.During functional testing the device was advanced down an olympus 2.8 mm channel endoscope in a simulated upper gi position with the tip in the maximum retroflexed position to simulate a worst-case position.With handle manipulation, the drive wire was observed to move freely inside the outer sheath.A visual examination of the drive wire, catheter attachment, and coil catheter (distal end device components) showed no deformities or signs of damage.A product discrepancy or anomaly that could have contributed to the reported occurrence was not observed.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 the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation, the clip had been deployed.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.The system preparation section of the instructions for use includes the following: "uncoil device.Verify smooth handle operation and clip action.Open clip by gently moving handle spool distally (away from handle thumb ring).Once clip is fully open, do not continue advancing handle spool as clip may prematurely detach from catheter.Close clip by moving handle spool proximally until clip is fully closed.Caution: do not continue to pull handle spool beyond tactile resistance as this may prematurely deploy clip." prior to distribution, all instinct plus endoscopic clipping device 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: a review of the complaint history was conducted and this represents an isolated occurrence.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: INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
• Type of Device: PKL, LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 12333356
• MDR Text Key: 267042871
• Report Number: 1037905-2021-00389
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 00827002580107
• UDI-Public: (01)00827002580107(17)220119(10)W4428465
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2022
• Device Model Number: G58010
• Device Catalogue Number: INSC-P-7-230-S
• Device Lot Number: W4428465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Date Manufacturer Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS ENDOSCOPE GIF-H190.