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

Model Number	G24653
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
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 product lot number was received necessitating review of the device history record; therefore, the investigation is on-going.A follow-up medwatch report will be provided within 30 days of submission of this report with product evaluation information.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: "visually inspect with particular attentions to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." the instructions for use state: "uncoil device.Verify smooth handle operation and clip action." prior to distribution, all instinct endoscopic hemoclips are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.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 or Problem Description
During a clipping procedure, the physician used a cook instinct endoscopic hemoclip.The clip deployed prematurely after the catheter was in position.Additional information was received indicating that the clip prematurely deployed during advancement through the endoscope.According to the physician, when [they] attempted to open the clip, one of the "tines" broke.Clarifying information received indicated that the "doctor responded back and was referring to the 'clip arm' and not the nitinol strip.Also, the doctor noted that nothing was left behind in the patient as it [the device] was immediately removed.Please note, they don¿t exactly know when or how the clip arm broke.[it was] most likely outside the patient when examining the clip.There are lots of uncertainties in the physician's follow-up, as staff are not familiar with over-all functioning of the instinct clip." further information was received noting that the endoscope was torqued/angled and in the distal duodenum controlling a bleed.The instinct clip was checked before using with closing and opening the clip.When the clip was advanced down the accessory channel of the endoscope and in position for use, it was at that point the clip would not open and had to be removed from the endoscope.A subsequent clip was used to complete the case.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: "visually inspect with particular attentions to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." the instructions for use state: "uncoil device.Verify smooth handle operation and clip action." prior to distribution, all instinct endoscopic hemoclips are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.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 or Problem Description
During a clipping procedure, the physician used a cook instinct endoscopic hemoclip.The clip deployed prematurely after the catheter was in position.Additional information was received indicating that the clip prematurely deployed during advancement through the endoscope.According to the physician, when [they] attempted to open the clip, one of the "tines" broke.Clarifying information received indicated that the "doctor responded back and was referring to the 'clip arm' and not the nitinol strip.Also, the doctor noted that nothing was left behind in the patient as it [the device] was immediately removed.Please note, they don¿t exactly know when or how the clip arm broke.[it was] most likely outside the patient when examining the clip.There are lots of uncertainties in the physician's follow-up, as staff are not familiar with over-all functioning of the instinct clip." further information was received noting that the endoscope was torqued/angled and in the distal duodenum controlling a bleed.The instinct clip was checked before using with closing and opening the clip.When the clip was advanced down the accessory channel of the endoscope and in position for use, it was at that point the clip would not open and had to be removed from the endoscope.A subsequent clip was used to complete the case.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.

• 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: 7773519
• Report Number: 1037905-2018-00352
• Device Sequence Number: 1392052
• Product Code: PKL
• UDI-Device Identifier: 00827002246539
• UDI-Public: (01)00827002246539(17)201012(10)W3930323
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2018

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: 10/12/2020
• Device Model Number: G24653
• Device Catalogue Number: INSC-7-230
• Device Lot Number: W3930323
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS ENDOSCOPE - UNKNOWN MODEL