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

Model Number G58010

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

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

Event Date 09/13/2021

Event Type  malfunction  

Event Description

During an esophagogastroduodenoscopy (egd) poem procedure, a cook instinct plus endoscopic clipping device was used.When the physician attempted to open the clipping device, the drive wire came out and the clip would not open, in a thrombosing fashion.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): 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 as it was described.The deployed clip was returned attached to the device in the closed position.Under visual magnification, the cath attach was observed outside of the housing and attached at the proximal end of the clip.The coil cath tabs do not appear crimped, this would allow the cath attach to slide out of the housing and remain attached to the clip.The device was viewed before deployment, and the cath attach was not bottoming out inside the coil cath while the clip was attached.A function test was attempted, in order to deploy the clip.With handle manipulation the device deployed the clip.After deployment, the cath attach could be seen bottoming out inside the coil cath.The device was sent back to the supplier for further evaluation.The supplier provided the following: visual evaluation: the coil tabs are not crimped.Functional evaluation: our laboratory evaluation of the product said to be involved confirmed the report as it was described.The clip was returned deployed from the device in the closed position, therefore, functional testing for open and close issues could not be performed.The tabs on the coil cath are not crimped which could allow the cath attach to slide out of the housing and remain attached to the clip.The complaint was confirmed.The root cause is human error.Process traveler was reviewed and 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.The supplier provided the following: corrective actions were implemented for visual standards, process verification, and revision of work instructions.All operators involved in the instinct plus clip assembly have been trained on these documents.The complaint was confirmed and corrective actions have been initiated.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: 12599057
• MDR Text Key: 281924462
• Report Number: 1037905-2021-00563
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 00827002580107
• UDI-Public: (01)00827002580107(17)240506(10)W4468495
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G58010
• Device Catalogue Number: INSC-P-7-230-S
• Device Lot Number: W4468495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS 190 SCOPE