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

Model Number G18343

Device Problem Premature Separation (4045)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The instructions for use states: "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 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: 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.

Event Description

During a colonoscopy, the physician used a cook instinct endoscopic hemoclip.The clip fell on the floor prior to insertion.Additional hemoclips were used to complete the procedure.This occurred prior to patient contact; there was no impact to the patient.

• 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 (Section G): 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: 9560546
• MDR Text Key: 220825645
• Report Number: 1037905-2020-00013
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 00827002183438
• UDI-Public: (01)00827002183438(17)220828(10)W4255582
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2022
• Device Model Number: G18343
• Device Catalogue Number: INSC-7-230-S
• Device Lot Number: W4255582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2019
• 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