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

Model Number	G18344
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Non-healthcare professional.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: "uncoil device.Verify smooth handle operation and clip action.Open clip by gently moving handle spool distally (away from handle thumb ring).Once clip is fully open, do not continue advancing handle spool as clip may prematurely detach from catheter.Close clip by moving handle spool proximally until clip is fully closed.Caution: do not continue to pull handle spool beyond tactile resistance as this may prematurely deploy clip." the instructions for use includes the following precaution: "endoscope must remain as straight as possible when inserting or withdrawing device." the instructions for use also states: "with clip closed and without holding handle spool, advance device in small increments into accessory channel of gastroscope or colonoscope.Caution: holding handle spool during advancement may prematurely deploy clip." failure to follow the instructions above can result in damage to the device which may lead to premature clip deployment.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: 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.
Event or Problem Description
During a clipping procedure, the physician used a cook instinct endoscopic hemostat.The following is the event description listed on the maude report (b)(4): "a clip deployed inside scope prior to use.Physician noted that while he was advancing clip catheter down the biopsy channel he met some resistance and when the catheter came through the tip of the scope that the clip was detached." the following was selected on the maude report: "date report to manufacturer: 08/08/2019"; however, no reports of this nature have been received regarding this device with the same rpn, lot number, date of event, or any combination of available information.We are attempting to collect additional information regarding patient outcome from the three user facilities found to have purchased the lot number listed on the maude report.While the maude report did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information published does not reasonably suggest the patient was adversely impacted.

• Brand Name: INSTINCT ENDOSCOPIC HEMOCLIP
• Common Device Name: PKL, LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 9216203
• Report Number: 1037905-2019-00624
• Device Sequence Number: 2181380
• Product Code: PKL
• UDI-Device Identifier: 00827002183445
• UDI-Public: (01)00827002183445(17)220502(10)W4210807
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/26/2019

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: 05/02/2022
• Device Model Number: G18344
• Device Catalogue Number: INSC-7-230-20-S
• Device Lot Number: W4210807
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1