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

Catalog Number INSC-P-7-230-S

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

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

Event Type  malfunction  

Manufacturer Narrative

Initial reporter; occupation: unknown.Pma/510(k) # k192697.The investigation is on-going.A follow-up emdr will be provided upon completion.

Event Description

During endoscopic clipping procedures, the physician used three (3) cook instinct plus endoscopic clipping devices.The clips did not detach from the drive mechanism after they were attached to the tissue.They could be reopened for removal from the tissue.A 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

Section e.Initial reporter; occupation: unknown.Section g: pma/510(k) # k192697.Investigation evaluation: 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 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.However, with handle manipulation and light touching of the clip on the table, the device would not deploy the clip.The device was sent back to the supplier for further evaluation.The supplier provided the following: visual evaluation: the coil cath tabs are not crimped.Functional evaluation: our laboratory evaluation of the product said to be involved confirmed the report as it was described.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.A function test was not performed.The complaint was confirmed.Root cause is unknown.A device history record review was not possible, the lot number was not provided.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.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: 12407153
• MDR Text Key: 270612893
• Report Number: 1037905-2021-00464
• Device Sequence Number: 1
• Product Code: PKL
• 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,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: INSC-P-7-230-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Date Manufacturer Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS ENDOSCOPE, MODEL UNKNOWN