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 Gastrointestinal Hemorrhage (4476)

Event Date 04/15/2023

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k): k212323.Investigation evaluation: the product said to be involved was returned in 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 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.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 an upper gi endoscopy, the physician used an instinct plus endoscopic clipping device.It was reported that when the clip handle was opened, the wire was visualized, and we visualized the clip falling off of the wire.The clip remained in the duodenum.An unintended section of the device did not remain inside the patient¿s body.The closed clip was left to pass naturally.Epinephrine was injected to control bleeding.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: 16910722
• MDR Text Key: 314989735
• Report Number: 1037905-2023-00215
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 00827002580107
• UDI-Public: (01)00827002580107(17)251121(10)W4658550
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/11/2023

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
• Device Operator: Health Professional
• Device Model Number: G58010
• Device Catalogue Number: INSC-P-7-230-S
• Device Lot Number: W4658550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2022
• 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: SCOPE, UNKNOWN MAKE AND MODEL.
• Patient Age: 90 YR
• Patient Sex: Male
• Patient Weight: 64 KG