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

Model Number G58010

Device Problems Material Separation (1562); Difficult to Open or Close (2921)

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

Event Date 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k): k212323.Investigation evaluation: the product said to be involved was returned in a plastic bag with an open pouch from the lot number provided in the report.The label matches the product returned.Additionally, two sealed devices from the lot number said to be involved were returned and evaluated.Used device #1: our laboratory evaluation of the product said to be involved confirmed the report.A visual examination confirmed the clip housing has separated from the coil catheter but remains attached to the end of the drive wire, in a closed position.The clip could not be reopened.The device was viewed under magnification and a product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.Sealed devices #2 - #3: the devices were functionally tested to verify open/close and the cath attach to housing joint strength.The clips advanced through the scope, opened, and closed as expected.Additionally, the clips did not separate from the cath attach when opened.A functional test was then performed for the housing to catch attach joint tensile strength.The devices separated at the cath attach at a detachment force within the acceptance criteria.Therefore, the complaint could not be confirmed for the sealed devices.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 corrective action has been initiated to reduce occurrences of the clip housing detaching from the cath attach for instinct plus endoscopic clipping devices.The product said to be involved is included in the scope of the corrective actions.Used, returned device: our laboratory evaluation of the returned device confirmed the report.Sealed devices: a definitive cause for the reported observation could not be determined because the product said to be involved functioned as intended.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.The instructions for use states: "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.Precaution: do not continue to pull handle spool beyond tactile resistance as this may prematurely deploy clip.".The instructions for use states: "with clip closed and without holding handle spool, advance device in small increments into accessory channel of gastroscope, duodenoscope, or colonoscope.Note: if difficult to advance device, relax elevator and/or straighten endoscope.¿.The ifu also includes the following precaution: ¿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.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 corrective action has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of this corrective action.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 colonoscopy to remove polyps in the descending colon and caecum, the physician used a cook instinct plus endoscopic clipping device.It was reported that the clip would not open.This initial report was not considered a reportable event because it has not historically required intervention to preclude death or serious injury.The device was received for evaluation on (b)(6) 2023 and per initial qe evaluation, "the clip housing has separated from the cath attach but remains attached to the drive wire [moved in a tromboning motion]".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: 16938392
• MDR Text Key: 315301992
• Report Number: 1037905-2023-00225
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 00827002580107
• UDI-Public: (01)00827002580107(17)251213(10)W4664675
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• 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: W4664675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2022
• 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: OLYMPUS COLONOSCOPE