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It was reported an unknown patient required an entuit secure gastrointestinal suture anchor set for an unknown procedure.During the procedure, the operator noticed the wire "frayed".As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
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Investigation ¿ evaluation: it was reported to cook that an entuit secure gastrointestinal suture anchor set that the wire used with the anchoring system frayed during placement, two wires were used but the same problem occurred.This incident was reported by centre hospitalier broussais, in france.Further communication with the user facility clarified that the wire guide was frayed, the procedure proceeded as usual and completely normal, and that there was no difficulty in sliding the bolster along the suture.Attempts to acquire device return from the user facility were executed, however the device was not provided to cook in response to this incident.No adverse effects were reported.A review of the complaint history, device history record, instructions for use (ifu), quality control of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.Product labeling was also reviewed.Instructions for use are packaged with this device.Relevant sections include: instructions for use ¿6.While maintaining slight tension on the trailing suture, introduce the distal spring coil of the wire guide into the needle and use it to push the anchor out of the needle into the stomach cavity.7.Remove the introducer needle over the wire guide.8.With the wire guide still in position, apply traction to the suture to pull the anterior wall of the stomach against the abdominal wall.9.While maintaining traction on the suture, remove the wire guide.15.Advance an.035 inch wire guide through the access needle into the gastric lumen.16.Maintaining wire guide position, remove the access needle.17.The wire guide may now be used to facilitate introduction of fascial dilators, peel-away sheaths, and the gastrotomy catheter.¿ a review of the device history record (dhr) was also conducted as a part of the investigation.The dhr for the complaint lot and related subassembly lots found , a relevant non-conformance was recorded, one device had offset coil and was scrapped as a result.A data base search revealed no additional complaints for the complaint lot from the field.Adequate inspection activities have been established (100% tensile test, outside diameter and visual inspection), there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, therefore it was concluded that there is no evidence that non-conforming product exists in house or in field.Based on the information provided, no returned product and the results of the investigation, a definitive cause could not be established.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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