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

Catalog Number INSC-7-230-S

Device Problem Separation Failure (2547)

Patient Problems Hemostasis (1895); Tissue Damage (2104); No Consequences Or Impact To Patient (2199)

Event Date 03/11/2016

Event Type  Injury  

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 conclusions: 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 state: "if clip deployment device is used with endoscope in a torqued or retroflexed position, clip deployment difficulties can occur." during an attempt to deploy the clip, the device components are altered as the drive wire begins to pass through the clip driver.Once this occurs, the clip is in a partially deployed state and opening/reopening the clip jaws may not be possible.Prior to distribution, all instinct endoscopic hemoclips 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: 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 gastroscopy procedure, the physician used a cook instinct endoscopic hemoclip.[the physician was] placing a clip for an ulcer with visible vessel during a gastroscopy, once closed on the vessel, it was impossible to release the clip.They had take the clip off which involved more bleeding.They retrieved the clip and used another clip from another manufacturer.The following information was received via the cook complaint reporting form on 06/22/2016: "because of an ulcer of the antrum, the doctor decided to put a clip on the visible vessel, but when tightening, it was impossible to release it from its sheath.He had ripped the clip off the vessel and removed the endoscope.He took another clip from another manufacturer for placing on the vessel.Finally, no unfortunate consequences for the patient, even if this maneuver could worsen bleeding.The patient was under previscan anticoagulents.A gastroscopy for control was made on (b)(6).The clip had disappeared and the patient is doing well.When the instinct clip was removed from the endoscope, it was still closed so no damages for the endoscope." clarification was received on 06/24/2016 that the gastroscopy for control was done as a routine procedure and was not related to the malfunction of the cook instinct endoscopic hemoclip.

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report and found that the drive wire was not visible in the distal end device components.This is an indication that the hook has broken at the distal end of the drive wire.The clip was removed from the deployment catheter and the broken portion of the hook was located within the clip housing.Therefore no piece of the device is missing.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 conclusions: 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.Resistance encountered while attempting to deploy the clip after the clip is closed on the tissue (i.E.Difficulty with clip release) can lead to damage of device components such as the hook at the distal end of the drive wire.The instructions for use system preparation instructs the user to "verify smooth handle operation and clip action" prior to use.Instructions for use states: "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." prior to distribution, all instinct endoscopic hemoclips 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: 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
• Type of Device: PKL, LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): 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: 5764817
• MDR Text Key: 48637357
• Report Number: 1037905-2016-00200
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 00827002183438
• UDI-Public: (01)00827002183438(17)180420(10)W3564671
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K132809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: INSC-7-230-S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/11/2016
• Device Age: 14 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/09/2016
• Initial Date FDA Received: 07/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR