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

Model Number G58010

Device Problems Nonstandard Device (1420); Separation Failure (2547); Failure to Fire (2610)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2021

Event Type  malfunction  

Manufacturer Narrative

510(k): k192697.This investigation is ongoing and a follow up emdr will be submitted upon completion.

Event Description

During an endoscopic clipping procedure, the physician used a cook instinct plus endoscopic clipping device.The clip would not release from the drive wire.They were able pull it off the lesion without causing any damage.The procedure was successfully completed with additional devices of the same type.An unintended section of the device did not remain inside the patient¿s body.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

510(k): k192697.Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved confirmed the report.The deployed clip was returned attached to the device in the closed position.Under visual magnification, the coil cath tabs do not appear sufficiently crimped.This would allow the cath attach to slide out of the housing and remain attached to the clip.The cath attach was pushed out of the coil cath, showing the crimp was insufficient.A function test was attempted, in order to deploy the clip.The handle was manipulated, and the clip was lightly touched on the table surface.This caused the clip to fully deploy.The device was viewed again under magnification to examine the driver legs in the clip.There were no other anomalies found.The device was sent back to the supplier for further evaluation.The supplier provided the following: visual evaluation: the device tip is deployed and returned separated from the coiled cable.The coil cath tabs are not crimped.Functional evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.A functional test could not be performed since the device tip has been deployed.The returned components were looked at under magnification.The following observations were made: jaws are contacting top of housing.Pins are bottomed out in housing slots.Cath attach is contacting the tabs in the coil cath.This indicates that the device tip has been deployed as intended.The coil cath tabs allow for the tip to rotate and hold the housing to the coil cath so that the device tip can open.Since the cath attach is separated from the housing and is contacting the tabs of the coil cath it can be determined that they did not interfere with the deployment of the device tip.Complaint confirmed for insufficient tab crimp.Process traveler was reviewed, no relevant defects were noted.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 root cause is an incorrectly manufactured the device.The cause of the manufacturing failure is unknown.The supplier has initiated a change to their process to include additional verifications that will prevent reoccurrence.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.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: 12421471
• MDR Text Key: 270617338
• Report Number: 1037905-2021-00476
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 00827002580107
• UDI-Public: (01)00827002580107(17)240429(10)W4466364
• 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: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2024
• Device Model Number: G58010
• Device Catalogue Number: INSC-P-7-230-S
• Device Lot Number: W4466364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Date Manufacturer Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS ENDOSCOPE, UNKNOWN MODEL