COOK ENDOSCOPY ACUSNARE POLYPECTOMY SNARE; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Catalog Number ASM-1-S |
Device Problems
Failure to Conduct (1114); Off-Label Use (1494); Retraction Problem (1536)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/04/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: electrosurgical generator - unknown make and model.Investigation evaluation: a product evaluation was performed only by the pictures provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photo provided the sheath exhibits some kinking/buckling near the base of the handle.The kinking/buckling near the base of the handle is due to the device being used without an electrosurgical unit.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on statements describing the event.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.The additional information provided by the user stated that a cold polypectomy was performed.This is against the intended use of the device.The instructions for use intended use for this device states: "this device is used with an electrosurgical unit for endoscopy polypectomy.Do not use this device for any purpose other than the stated intended use." a possible contributing factor of the sheath becoming kinked/buckled near the base of the handle was due to the device being used for a cold polypectomy procedure, which places additional stresses on the catheter.The instructions for use contains the following information to assist with proper set-up and use of the device: "before using this device, follow recommendations provided by electrosurgical unit manufacturer to ensure patient safety through proper placement and utilization of patient return electrode.Ensure a proper path from patient return electrode to electrosurgical unit is maintained throughout the procedure." "inspect active cord.Cord must be free of kinks, bends, breaks and exposed wires to allow for accurate transfer of current.If an abnormality is noted, do not use active cord." "with electrosurgical unit off, prepare equipment.Securely connect active cord to device handle and electrosurgical unit.Active cord fittings should fit snugly into both device handle and electrosurgical unit.Following instructions from electrosurgical unit manufacturer, position patient return electrode and connect it to electrosurgical unit." "following electrosurgical unit manufacturer's instructions for settings, verify desired settings and activate electrosurgical unit.Note: maximum rated input voltage for this device is 2 kvp-p for cut mode and 5 kvp-p for coagulation mode." prior to distribution, all acusnare polypectomy snares 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.Additional comments regarding this report: based on the information provided that the product was used for cold snaring, a cook representative has contacted the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
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Event Description
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During a colonoscopy procedure, the physician used a cook acusnare polypectomy snare.The catheter appears to be twisted or looped close to the handle.There was no reportable information at this time.Additional information received on 10/13/2017: the heat was not conducted through the snare as it was supposed to, when the polyp was cut.They had to throw away the snare and use a different one [difficulty with conducting electrical current during use].The following additional information was provided from the customer on 10/19/2017: "the problem i noticed both times [first occurrence - see related mdr 1037905-2017-00676, second occurrence - subject of this report, third occurrence - see related mdr 1037905-2017-00678] was close to the handle, just a couple of cm away.It seems like the wire would twist inside the plastic protector.Therefore, it made it very difficult to open or close the snare properly [difficult retraction].When i noticed the issue, i tried to pull on the plastic to straighten it and it worked.But as soon as i tried to open the snare again, it would twist and reform.It was the same issue.At first, i thought it was just the plastic that was causing the issue, but upon having a good look at it, i noticed it came from the wiring inside." had to throw away the snare and use a different one [difficulty with conducting electrical current during use].The following additional information was provided from the customer on 10/19/2017: "the problem i noticed both times [first occurrence - (b)(4), second occurrence - (b)(4), third occurrence - (b)(4)) was close to the handle, just a couple of cm away.It seems like the wire would twist inside the plastic protector.Therefore, it made it very difficult to open or close the snare properly [difficult retraction].When i noticed the issue, i tried to pull on the plastic to straighten it and it worked.But as soon as i tried to open the snare again, it would twist and reform.It was the same issue.At first, i thought it was just the plastic that was causing the issue but upon having a good look at it, i noticed it came from the wiring inside." additional information was received on 10/26/2017 from the cook area representative: first off, they have been using our snares in a ¿cold fashion¿ for at least 6 years or so.All snares were used in similar fashion.They were initially using the snare as a cold snare, it was not initially used with electro-cautery.Then, the snare was connected to an electro-cautery [unit] and it did not conduct current.
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