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

Model Number G18343

Device Problems Break (1069); Failure to Fire (2610); Activation Failure (3270)

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

Event Date 01/18/2021

Event Type  malfunction  

Event Description

During a colonoscopy of the sigmoid colon, a cook instinct endoscopic hemoclip was used.The clip did not release [difficult to deploy].Additional information received states the clip was difficult to deploy once attached to 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

510(k): k192697.The investigation is ongoing.A follow up emdr report will be sent within 30 days for the completed evaluation.

Manufacturer Narrative

510(k): k192697.Investigation evaluation: the product was received in an open pouch from the lot number in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved confirmed the report based on the condition of the returned device.The device was returned with the clip attached and in the closed position.An attempt was made to open the clip outside an endoscope, however the clip did not respond to handle manipulation.During a visual inspection of the clip, while it was still attached, a piece of the drive wire hook was visible through the slots of the coil cath when the handle was advanced in the open direction.When the handle was retracted slightly towards the closed position, the hook end of the drive wire was observed to be broken and no longer controlling the clip jaw movement.Therefore, the clip is partially deployed and remained attached to the deployment catheter by only the catheter attachment.The jaws of the clip were manually pulled open, with the clip jaw open the remaining portion of the drive was visible through the clip slots, no portion of the drive wire was missing.The drive extension was also observed to be correct.A close visual examination of all other distal end component showed no other anomalies.The broken drive wire is an indication that a significant force has been applied to the handle of the device in the deployment direction.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 this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.In addition, due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.Resistance encountered while attempting to deploy the clip after the clip is closed on the tissue (i.E.Difficulty with clip release) can lead to damage of device components such as the hook at the distal end of the drive wire.The instructions for use instruct the user to "verify smooth handle operation and clip action." the instructions for use state, "to permanently deploy clip, pull handle spool toward handle thumb ring until clip detaches.Note: if separation of clip is not immediate, gently move catheter back and forth or use other endoscopic maneuvers to separate catheter from 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 remote.This type of damage is unusual.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 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: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 13513584
• MDR Text Key: 288180599
• Report Number: 1037905-2022-00054
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 00827002183438
• UDI-Public: (01)00827002183438(17)240303(10)W4444651
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2024
• Device Model Number: G18343
• Device Catalogue Number: INSC-7-230-S
• Device Lot Number: W4444651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2021
• 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
• Treatment: PENTAX EC38-I10L.
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 60 KG