MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC INSTINCT ENDOSCOPIC HEMOCLIP; PKL, LIGATOR, HEMORRHOIDAL

Model Number	G18343
Medical Device Problem Codes	Use of Device Problem (1670); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an endoscopic procedure to stop arterial bleeding in the fundus.The physician used a cook instinct plus endoscopic clipping device.It was reported, that when the distal part of the clip appeared in the endoscopy image, its tip part was partially detached from the catheter [moved in a tromboning manner] (reported under 1037905-2023-000830.Multiple devices from various lots were returned and per rep response received 04/05/2023."they returned all the clips used in [this] procedure, because they were not sure if the problem was due to a manufacturing error.There were difficulties with all the returned clips.After discussing with them, it became clear, that it was apparently a handling error and i have given them a new in-service".These additional clips are from lot w4589669 and are captured under this report.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.
Additional Manufacturer Narrative
Investigation evaluation: the products said to be involved were returned together in a biohazard bag with 8 open pouches, 2 from the lot number provided in this report.Device 1 & 2: 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 a functional test, the device was advanced into the accessory channel of an olympus gastroscope (2.8mm channel, gif-020), which was placed in a simulated upper 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, 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: the additional information indicated the user held the handle spool during advancement through the accessory channel.This is the most likely root cause of this report.The instructions for use states: "with clip closed and without holding handle spool, advance device in small increments into accessory channel of gastroscope or colonoscope.Caution: holding handle spool during clip advancement may prematurely deploy clip".Failure to follow the instructions above can result in damage to the device which may lead to premature clip deployment.However, even if the clip is not deployed, damage can occur to internal device components such as the driver legs.Once this damage occurs, the clip is in a partially deployed state and may not be able to be opened/reopened.Prior to distribution, all instinct endoscopic hemoclips are subjected to a visual and functional inspection 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.Additional comments regarding this report: based on the information provided that the handle spool was being held when passing the device through the endoscope, a cook representative has contacted the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

• Brand Name: INSTINCT ENDOSCOPIC HEMOCLIP
• Common Device Name: PKL, LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 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 Key: 16831592
• Report Number: 1037905-2023-00195
• Device Sequence Number: 1929694
• Product Code: PKL
• UDI-Device Identifier: 00827002183438
• UDI-Public: (01)00827002183438(17)250426(10)W4589669
• Combination Product (Y/N): N
• PMA/510(K) Number: K132809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2023

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: Health Professional
• Device Expiration Date: 04/26/2025
• Device Model Number: G18343
• Device Catalogue Number: INSC-7-230-S
• Device Lot Number: W4589669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCOPE UNKNOWN MAKE AND MODEL
• Patient Sex: Unknown