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

Catalog Number	INSC-7-230-S
Medical Device Problem Codes	Separation Failure (2547); Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an unspecified procedure, the physician used a cook instinct endoscopic hemoclip.It was reported that the clip did not deploy when inside the patient.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.
Additional Manufacturer Narrative
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 state: "to permanently deploy clip, pull handle spool toward handle thumb ring until clip detaches.Note: if separation of clip is not immediate, gently move catheter back and forth or use other endoscopic maneuvers to separate catheter from clip." the instructions for use include the following precaution: "if clip deployment device is used with endoscope in a torqued or retroflexed position, clip deployment difficulties can occur." 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 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.
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a biohazard bag (with a micro label) and a clear bag with the front part of a 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 confirmed the report.During a visual examination, there was no damage to the catheter or clip noted.The clip opened and closed with some resistance.The device was advanced into a pentax colonoscope (2.8 mm channel) in a simulated lower gi position with the tip in the maximum retroflexed position to simulate a worst-case position.In this endoscope position, the clip required a significant amount of back and forth movement of the device sheath in order to open and close.The clip was closed on two layers of simulated tissue and deployed.Deployment required a significant amount of back and forth movement of the sheath and an excessive amount of pressure had to be applied to the handle spool.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: our laboratory evaluation of the complaint confirmed the report for clip being unable/difficult to deploy once attached to tissue.During our functional evaluation a significant amount of force and sheath movement was required for the clip to deploy.A definitive cause for this observation could not be determined.The instructions for use state: "to permanently deploy clip, pull handle spool toward handle thumb ring until clip detaches.Note: if separation of clip is not immediate, gently move catheter back and forth or use other endoscopic maneuvers to separate catheter from clip." the instructions for use include the following precaution: "if clip deployment device is used with endoscope in a torqued or retroflexed position, clip deployment difficulties can occur." 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 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 ENDOSCOPIC HEMOCLIP
• Common Device Name: 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: 17512046
• Report Number: 1037905-2023-00382
• Device Sequence Number: 12810360
• Product Code: PKL
• UDI-Device Identifier: 00827002183438
• UDI-Public: (01)00827002183438(17)250609(10)W4603961
• Combination Product (Y/N): N
• PMA/510(K) Number: K132809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2025
• Device Catalogue Number: INSC-7-230-S
• Device Lot Number: W4603961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS WM-NP2
• Patient Sex: Unknown