|
COOK ENDOSCOPY CAPTURA MINI BIOPSY FORCEPS W/O SPIKE; FCL, FORCEPS, BIOPSY, NON-ELECTRIC
|
Back to Search Results |
|
| Catalog Number DBF-1.8-160-S |
| Device Problems
Device Operates Differently Than Expected (2913); Device-Device Incompatibility (2919)
|
| Patient Problem
No Consequences Or Impact To Patient (2199)
|
| Event Date 04/03/2018 |
|
Event Type
malfunction
|
|
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 nonconformances documented for the lot number said to be involved were reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: the reporter indicated this device was introduced transnasally through a nasogastroscope.Even though our instructions for use do not explicitly state endoscope introduction, our expectation is the device should be placed through a compatible endoscope that has been introduced orally.The instructions for use state the following in regards to product inspection: "beginning at the handle and moving toward the cups, uncoil the forceps making sure not to stretch the cable.Open and close the cups to verify smooth handle operation and appropriate cup action.Become familiar with the amount of handle movement required to operate the cups.If any irregularities are noted, do not use.Note: exercising the handle while the forcep is coiled may result in damage to the performance characteristics of the forceps." the instructions for use states, "with cups closed, insert forceps into accessory channel.Note: keep end of forceps extending from accessory channel straight at all times.Allowing forceps to hang from accessory channel may cause damage to forceps." the instructions for use states, "using slight pressure on handle, close forceps around tissue or object.Note: it is not necessary to apply excessive pressure to cleanly excise tissue.Caution: if forceps fail to close, slowly pull cups against channel opening.Remove endoscope and forceps as a unit, then manually close cups and withdraw forceps from endoscope." prior to distribution, all captura mini biopsy forceps w/o spike are subjected to a visual inspection and functional test to ensure proper workability.The nonconformances documented 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.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 device was used trans-nasally in a nasogastroscope, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
|
| |
|
Event Description
|
|
During a biopsy procedure, the physician used a cook captura mini biopsy forceps w/o spike.The forceps were not opening symmetrically and only closing partially.They did not come out of the operating channel during a nasogastroscopy without general anesthesia.The forceps were taken out [of the nasogastroscope] at the end of the procedure when the nasogsatroscope was out of the patient.Only one biopsy was done out of three [intended biopsies].Per the customer, there was a risk of damaging the endoscope.
|
| |
|
Manufacturer Narrative
|
|
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.When the device was received, the handle of the device was functionally tested.When the handle was manipulated the device will not open symmetrically.The device opens in an "l" shape and does not open properly.When the forceps cups are closed, one (1) of the cup flanges is protruding from the forceps cups housing.Additionally, when the handle is resting without any pressure being applied to it, the forceps cups will slowly open.Pressure has to be applied to the handle of the device in order to keep the forceps cups closed.A visual inspection under magnification was performed and the link wires between the forceps cups housing does not line up straight, instead the link wires appear to be crossing over one another.This could be preventing the forceps cups from opening symmetrically.Due to the forceps cups initially not opening correctly, and due to the cup flange protruding from the forceps cups housing, the device was not advanced through an endoscope.The device was sent to the supplier for further evaluation.The supplier provided the following response letter: one (1) device from the reported event was returned in a zip type bag with proof of decontamination.A functional evaluation for the returned device was performed.During testing, with the device coiled in two (2), eight (8) inch loops, it was confirmed that the device did not operate properly when the handle was manipulated.The device does not open correctly, but does close as intended.In the closed position, the cups appear skewed.The cups assembly appears to open as intended when partially open.Lastly, when in the full open position, the cups exhibit an "l" shape.The link wires and control wire on the returned device were evaluated.The device was disassembled to evaluate the link wires, control wire, and the solder connection.The link wires were evaluated while the cups assembly was in the open position, and no damage to the link wires was detected.Upon removal of the link wires and control wire from the device catheter, the link wires were determined to be completely detached from the solder connection.The root cause for the reported failure was attributed to detached link wires from the control wire/link wire solder connection.The device history records were reviewed and found to be manufactured january 2018.No relevant defects were noted in the manufacturing and/or final quality control checklist records.The nonconformances documented 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: the supplier provided the following: the reported issue for "would not open symmetrically and closure was not total" was confirmed.The root cause was due to detached link wires from the control wire/link wire solder connection.The operators involved have been advised of the complaint.The cause of the control wire/link wire solder connection is unknown.Additionally, the reporter indicated this device was introduced transnasally through a nasogastroscope.Even though our instructions for use do not explicitly state specific endoscope introduction, our expectation is the device should be placed through a compatible endoscope that has been introduced orally.The instructions for use state the following in regards to product inspection: "beginning at the handle and moving toward the cups, uncoil the forceps making sure not to stretch the cable.Open and close the cups to verify smooth handle operation and appropriate cup action.Become familiar with the amount of handle movement required to operate the cups.If any irregularities are noted, do not use.Note: exercising the handle while the forcep is coiled may result in damage to the performance characteristics of the forceps." the instructions for use state, "with cups closed, insert forceps into accessory channel.Note: keep end of forceps extending from accessory channel straight at all times.Allowing forceps to hang from accessory channel may cause damage to forceps." the instructions for use also state, "using slight pressure on handle, close forceps around tissue or object.Note: it is not necessary to apply excessive pressure to cleanly excise tissue.Caution: if forceps fail to close, slowly pull cups against channel opening.Remove endoscope and forceps as a unit, then manually close cups and withdraw forceps from endoscope." prior to distribution, all captura mini biopsy forceps w/o spike are subjected to a visual inspection and functional test to ensure proper workability.The nonconformances documented 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.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 device was used trans-nasally in a nasogastroscope, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
|
| |
|
Event Description
|
|
During a biopsy procedure, the physician used a cook captura mini biopsy forceps w/o spike.The forceps were not opening symmetrically and only closing partially.They did not come out of the operating channel during a nasogastroscopy without general anesthesia.The forceps were taken out [of the nasogastroscope] at the end of the procedure when the nasogsatroscope was out of the patient.Only one biopsy was done out of three [intended biopsies].Per the customer, there was a risk of damaging the endoscope.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.
|
| |
|
Search Alerts/Recalls
|
|
|
