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

Model Number G58010

Device Problem Premature Separation (4045)

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

Event Date 04/11/2023

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k): k212323.Investigation evaluation: the product said to be involved was returned in a clear bag with 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.The additional information indicated the user possibly held the handle spool during advancement through the accessory channel.This is a potential contributing cause of this report.The ifu also includes the following precaution: ¿holding handle spool during clip advancement may prematurely deploy clip.¿.The instructions for use include the following: "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.".Ifu also contains the following precautions: "do not continue to pull handle spool beyond tactile resistance as this may prematurely deploy clip.Failure to keep endoscope as straight as possible when inserting device can result in difficult passage.¿.The instructions for use also states: "with clip closed and without holding handle spool, advance device in small increments into accessory channel of gastroscope, duodenoscope, or colonoscope.¿.Failure to follow the instructions above can result in damage to the device which may lead to premature clip deployment.Prior to distribution, all instinct plus endoscopic clipping device 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.Additional comments regarding this report: based on the information provided the user possibly held the handle spool during advancement through the accessory channel, 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.

Event Description

During an unspecified procedure, the physician used a cook instinct plus endoscopic clipping device.It was reported that the clip just fell off of the catheter while the md was navigating the scope within the body of the patient.Per the cook representative, it appears that a couple of new employees are possibly mishandling the clips and we are working on remedial teaching of proper use of this device.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.

• Brand Name: INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
• Type of Device: 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: 16856860
• MDR Text Key: 314463024
• Report Number: 1037905-2023-00199
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 00827002580107
• UDI-Public: (01)00827002580107(17)251128(10)W4659811
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G58010
• Device Catalogue Number: INSC-P-7-230-S
• Device Lot Number: W4659811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCOPE UNKNOWN MAKE AND MODEL