MAUDE Adverse Event Report: COOK ENDOSCOPY INSTINCT ENDOSCOPIC HEMOCLIP; PKL, LIGATOR, HEMORRHOIDAL

Model Number G18343

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Tissue Damage (2104); No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: the photo provided by the user was reviewed, however, neither the deployment catheter nor distal end of the drive wire is shown in the photo.Therefore no conclusion can be made regarding device performance.The patient photo provided did confirm bleeding of the mucosa in the area the clip was placed our laboratory evaluation of the product said to be involved could not confirm the report.The device was returned with the clip deployed and the clip was not included with the return.The device was advanced into a pentax ec3830-tl colonoscope in a simulated lower gastrointestinal position with the tip in the maximum retroflexed position to simulate a worst case position.The hook of the drive wire was observed extending and retracting with a minimal amount of force applied to the handle.No resistance was observed that would have hindered complete retraction of the drive wire to hold the hook of the drive wire against the distal end of the deployment catheter after clip deployment and during removal of the endoscope.A close visual inspection of the drive wire hook did not show any abnormalities.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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 this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.In addition, due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The instructions for use states: "after clip deployment, continue to apply slight pressure on handle spool as device is removed from endoscope." this process would help prevent inadvertent contact of the hook end of the drive wire with tissue.Failure of the user to apply sufficient pressure on the handle spool as the device was removed from the endoscope likely contributed to the observation by the user.The investigation of the returned device confirmed the hook withdraws into the catheter appropriately.Prior to distribution, all instinct endoscopic hemoclips are subjected to a visual and functional inspection 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 remote.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.

Event Description

During a colonoscopy, the physician used a cook instinct endoscopic hemoclip.Clips were being used to clip a post-polypectomy site.The clips deployed without incident.Per the tech, she had the thumb ring closed and withdrew the catheter.On the first clip used, the hook was sticking out of the catheter as it got stuck on the biopsy channel adaptor (per customer, it did not retract appropriately).The second clip occurred in the same fashion, except it did not catch on the biopsy channel adaptor.It caught on the mucosa which caused a tear in the mucosa (subject of this report).The clip was fully removed from the patient and the physician did not use any further clips on the patient.The procedure was complete.An unintended 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 ENDOSCOPIC HEMOCLIP
• Type of Device: PKL, LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 7713439
• MDR Text Key: 114809833
• Report Number: 1037905-2018-00331
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 00827002183438
• UDI-Public: (01)00827002183438(17)210405(10)W4052602
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2021
• Device Model Number: G18343
• Device Catalogue Number: INSC-7-230-S
• Device Lot Number: W4052602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2018
• 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 190 SERIES ENDOSCOPE