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U.S. Department of Health and Human Services

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

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COOK ENDOSCOPY INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE; PKL, LIGATOR, HEMORRHOIDAL Back to Search Results
Model Number G58010
Device Problem Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/2021
Event Type  malfunction  
Manufacturer Narrative
510(k): k192697.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.Prior to distribution, all instinct plus endoscopic clipping devices 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 w/ multiple polypectomies, a cook instinct plus endoscopic clipping device was used.The clip deployed and then came off the tissue; it did not hold onto the tissue like it should.The procedure was successfully completed.Our attempts to collect specific patient outcome information were unsuccessful.Because the complainant stated that there was no clinical consequence to the patient, we can conclude that this information does not reasonably suggest the patient was adversely impacted.
 
Event Description
During a colonoscopy w/ multiple polypectomies, a cook instinct plus endoscopic clipping device was used.The clip deployed and then came off the tissue; it did not hold onto the tissue like it should.The procedure was successfully completed.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 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 into the accessory channel of a pentax colonoscope (2.8 mm channel) which was placed in a simulated lower gi position.The tip of the endoscope was retroflexed to simulate worst case scenario.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 and was not included in the return.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.Prior to distribution, all instinct plus endoscopic clipping devices 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.
 
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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
Manufacturer (Section G)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
sabrina o'brien
4900 bethania station rd
winston-salem, NC 27105
3367440157
MDR Report Key13018996
MDR Text Key285350283
Report Number1037905-2021-00695
Device Sequence Number1
Product Code PKL
UDI-Device Identifier00827002580107
UDI-Public(01)00827002580107(17)240504(10)W4467611
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/04/2024
Device Model NumberG58010
Device Catalogue NumberINSC-P-7-230-S
Device Lot NumberW4467611
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/27/2021
Initial Date FDA Received12/16/2021
Supplement Dates Manufacturer Received01/14/2022
Supplement Dates FDA Received02/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/04/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ENDOSCOPE, UNKNOWN MAKE OR MODEL.
Patient Age66 YR
Patient SexMale
Patient Weight92 KG
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