COOK ENDOSCOPY UNKNOWN; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Catalog Number UNKNOWN |
Device Problem
Off-Label Use (1494)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 07/31/2015 |
Event Type
Injury
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Manufacturer Narrative
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Antonello, a., ishaq, s., zanatta, l., cesarotto, m., costantini, m., & battaglia, g.(2015).The role of flexible endotherapy for the treatment of recurrent zenker¿s diverticula after surgery and endoscopic stapling.Surgical endoscopy, 30(6), 2351¿2357.Doi: 10.1007/s00464-015-4482-5.Concomitant medical products: cook soft duck bill diverticuloscope, zdo-22-30.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.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: the information received indicated that the device was used in the esophagus to treat a zenker's diverticula.This is outside the intended use of the device and the most likely cause for the reported observation.The intended use in the instructions for use for the possible devices states: huibregtse needle knife papillotome (hpc-2, hpc-3) - "this device is used for accessing the common bile duct when standard methods of cannulation have been exhausted and for papillotomy.This device is supplied sterile and is intended for single use only." the fusion triple lumen needle knife (fs-precut) - "this device is used for accessing the common bile duct when standard methods of cannulation have been exhausted." the zimmon needle knife papillotome (ptw, ptw-1e) - "these devices are used for accessing the common bile duct when standard methods of cannulation have been exhausted." prior to distribution, all needle knives are subjected to a visual inspection to ensure device integrity.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.Based on the information provided that the device was used off label, 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.
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Event Description
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Cook endoscopy was notified of an event that occurred with a cook needle knife, unknown model.Please see below for relevant excerpts of this article."double-incision technique was used in 18 patients (72 %), while in the remaining seven (28 %) single-incision technique was used.Treatment was carried out successfully in all patients.The needle knife (cook medical, winstonsalem, north carolina) was used in six patients, the hook knife (olympus, tokyo, japan) in nine and the sb knife (sumitomo-bakelite, tokyo, japan) in 15.Peri-procedural complications developed in two patients (8 % ): one microperforation (i.E., not visible during endoscopy but revealed by the post-procedural esophagram) and one case of moderate bleeding (subject of this report).The bleeding was successfully stopped by using hemostatic forceps (coagrasper; olympus, tokyo, japan).The patient did not require blood transfusions.The patient was kept npo [nothing by mouth] and under observation for 48 hr and then discharged.Both adverse events were graded as mild." it was not published in the article if a section of the device remained inside the patients' body.The bleeding was treated using hemostatic forceps.The patient was kept npo and under observation for 48 hours and then discharged.It is unknown if the patient experienced any adverse effects due to this occurrence, but no adverse effects were reported in the published case report.
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