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

Model Number	G18344
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continued from section e3.Occupation: non-healthcare professional investigation evaluation: the report is confirmed based on the fact the clip was inadevently deployed at the approved supplier during evaluation for difficulty to open and/or close.During a functional test, the device was advanced into the accessory channel of a pentax colonoscope (2.8 mm channel) which was placed in a simulated lower gastrointestinal (gi) position.The tip of the scope was retroflexed to simulate worst case scenario.With handle manipulation, the drive wire moved freely inside the outer sheath.A visual examination of the drive wire hook, catheter attachment, coil catheter and internal clip components (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: the clip was inadvertently deployed as the clip was being removed from the endoscope following the supplier's evaluation for difficulty to open.Both the cook evaluation and the supplier's evaluation required manipulation of the catheter at the endoscope port in order for the clip to open.This is a likely indication that the clip was in a partially deployed state.The clip likely completed the deployment process as it was being removed from the endoscope at the end of the supplier's evaluation.The instructions for use (ifu) state: "endoscope must remain as straight as possible when inserting or withdrawing device." the ifu states: "with clip closed and without holding handle spool, advance device in small increments into accessory channel of gastroscope.Caution: holding handle spool during advancement 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: 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 or Problem Description
During a colonoscopy, the physician used a cook instinct endoscopic hemoclip.The clip would not open.The device was removed and the physician used another clip to finish the procedure with no further complications.There was no reportable information at this time.The device was received for evaluation at cook endoscopy.It was then forwarded to the approved supplier for further evaluation.During the functional evaluation at the supplier, the clip prematurely deployed in the supplier's endoscope.This occurred post-patient contact at the supplier; there was no impact to the patient.

• Brand Name: INSTINCT ENDOSCOPIC HEMOCLIP
• Common Device Name: PKL, LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8697509
• Report Number: 1037905-2019-00332
• Device Sequence Number: 14022109
• Product Code: PKL
• UDI-Device Identifier: 00827002183445
• UDI-Public: (01)00827002183445(17)210712(10)W4092402
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2019

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
• Operator of Device: Other
• Device Expiration Date: 07/12/2021
• Device Model Number: G18344
• Device Catalogue Number: INSC-7-230-20-S
• Device Lot Number: W4092402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1