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

Model Number G58010

Device Problems Separation Failure (2547); Failure to Fire (2610)

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

Event Date 08/29/2022

Event Type  malfunction  

Event Description

During an unspecified procedure, the physician used two cook instinct plus endoscopic clipping devices.It was reported that while positioning the clips inside the patient and after acquiring the tissue, the clips would not deploy.They had to be removed and another company's clip was used.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

Pma/510(k): k212323.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The instructions for use states, "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 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 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.

Manufacturer Narrative

Pma/510(k): k212323.Investigation evaluation: the products said to be involved were returned in a clinical waste bag with two open pouches from the lot number provided in the report.The labels match the products returned.Device #1: our laboratory evaluation of the product said to be involved confirmed the report based on the condition of the returned device.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.A function test was attempted, in order to deploy the clip.With handle manipulation the clip deployed, with slight resistance encountered during deployment.A visual examination of the distal end components, clip, coil catheter and catheter attachment showed no deformities or signs of damage.During a functional test, the device was advanced into the accessory channel of a pentax colonoscope (2.8mm channel) which was placed in a simulated lower 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 panel, 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.Device #2: our laboratory evaluation of the product said to be involved could not confirm the report as it was described, the device functioned as intended.The clip opened and closed as intended outside of the endoscope.During a functional test, the device was advanced into the accessory channel of a pentax colonoscope (2.8mm channel) which was placed in a simulated lower 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.The clip was able to be deployed onto simulated tissue without any resistance.A visual examination of the drive wire panel, 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: device 1: our device evaluation confirmed the report.The evaluation identified the clip housing separated from the coil catheter but remains attached to the end of the drive wire, this device condition is the cause of the deployment difficulty.The cause of the housing separation from the coil catheter is unknown.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.Device 2: our functional evaluation of the returned device could not confirm the report.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, "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 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 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.

• 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: 15473731
• MDR Text Key: 306340270
• Report Number: 1037905-2022-00527
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 00827002580107
• UDI-Public: (01)00827002580107(17)250418(10)W4586650
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• 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: W4586650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2022
• 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.