MAUDE Adverse Event Report: COOK ENDOSCOPY INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE; PKL, LIGATOR, HEMORRHOIDAL

Model Number G58010

Device Problems Difficult or Delayed Positioning (1157); Separation Failure (2547); Failure to Fire (2610); Adverse Event Without Identified Device or Use Problem (2993); Difficult or Delayed Separation (4044)

Patient Problems Gastrointestinal Hemorrhage (4476); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k192697.The investigation is on-going.Once additional information has been received a follow-up emdr report will be provided.

Event Description

During an esophagogastroduodenoscopy (egd) procedure, the physician used three (3) cook instinct plus endoscopic clipping device.During the deployment stage, when the handle was squeezed to deploy the clips, the clips were not detaching from the catheters.The physician was attempting to clip a polyp defect, when they tried to detach the clip it caused a little bit more bleeding (they pulled on the catheter to try to get the device to release and it did not release).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 experienced some bleeding.

Manufacturer Narrative

Pma/510(k) # k192697.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.Device 1: 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 again observed to move freely inside the outer sheath.A visual examination of the drive wire showed a piece of plastic near the circular opening, possibly flash from the molding process or plastic deformation occurred during manufacturing or clip deployment.Plastic deformation could occur during the crimping process to attach the driver to the driver wire or during deployment when the heels of the driver have to slide over the distal end of the drive wire.This plastic deformation may have contributed to deployment difficulties.Device 2: 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 again 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.Device 3: 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 again 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.Our laboratory evaluation of the returned sealed device, from the same lot number as the used devices, confirmed the report for difficulty with deployment.Sealed device: the sample was function tested per test protocol for open/close and full deployment on simulated tissue.The clips opened and closed, and deployed as intended on simulated tissue, however endoscopic maneuvers were required to aid in deployment.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: used devices: 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.Sealed device: the catheter of the sealed device had to be moved back and forth, and the endoscope was moved side to side, in order to deploy the clip.These maneuvers are acceptable based on the ifu, however this does confirm the difficulty experienced by the customer.A corrective action has been initiated to reduce occurrences of deployment difficulty for instinct plus clips.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 corrective action has been initiated in an effort to reduce occurrences of this nature.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) # k192697.Investigation evaluation: 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.Device 1: 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 again 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.Device 2: 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 again 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.Device 3: 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 again 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.Our laboratory evaluation of the returned sealed device, from the same lot number as the used devices, confirmed the report for difficulty with deployment.Sealed device 1: the sample was function tested per test protocol for open/close and full deployment on simulated tissue.The clips opened and closed, and deployed as intended on simulated tissue, however endoscopic maneuvers were required to aid in deployment.Sealed device 2 returned 05/20/2021: the sample was function tested per test protocol for open/close and full deployment on simulated tissue.The clip met requirements, however endoscopic maneuvers were required to deploy.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: used devices: 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.Sealed devices: the catheter of the sealed device had to be moved back and forth, and the endoscope was moved side to side, in order to deploy the clip.These maneuvers are acceptable based on the ifu, however this does confirm the difficulty experienced by the customer.A corrective action has been initiated to reduce occurrences of deployment difficulty for instinct plus clips.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 corrective action has been initiated in an effort to reduce occurrences of this nature.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

This report is capturing a correction to annex a code.

• Brand Name: INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
• Type of Device: PKL, LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 11759569
• MDR Text Key: 267666204
• Report Number: 1037905-2021-00177
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 00827002580107
• UDI-Public: (01)00827002580107(17)211214(10)W4416642
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2021
• Device Model Number: G58010
• Device Catalogue Number: INSC-P-7-230-S
• Device Lot Number: W4416642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Date Manufacturer Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS ENDOSCOPE, PCFH190L
• Patient Age: 60 YR