|
The healthcare professional reported that during a revision primary functional endoscopic sinus surgery procedure, the accuracy of the devices were off by approximately 4mm along the skull base and the sphenoid sinus.The reported accuracy issue affected a 0° trudi nav suction device (tdns000z / lot# unknown), a curved suction device (catalog / lot# unknown), and a 4mm zero-degree shaver blade (catalog / lot # unknown).No troubleshooting was performed.The procedure continued without resolution.It was reported that this was a recurring issue in the trudi system (s/n: 100121).The software version used was confirmed to be 2.3.3.The reporter was unable to provide any information related to the disposable device that had accuracy issues; the suction devices are retained by the site and the shaver blade was discarded.There was no report of any negative patient impact.The patient¿s condition after the procedure was reported to be ¿fine.¿ the patient¿s most current status is reported to be ¿fine.¿ on 24-apr-2024, additional information was received.Per the information, accuracy was confirmed using the registration probe after registration process was completed.Accuracy was confirmed via known landmarks in endoscopic visualization inside the patient¿s nasal cavity.The information indicated that the inaccuracy was determined by visualization and endoscopic view with instrumentation.Registration probe was used to validate accuracy.Computed tomography (ct) image was used as the primary image.All views were utilized.There were no noticeable defects to the ct scanned image.The information indicated that the physician performed the registration process; this was not the physician¿s first time performing registration.Accuracy was confirmed along all areas of the ct scan ¿ perimeter and anatomical structures.The registration process was restarted / redone after the initial findings three (3) times.There was no potential for metal interference.Case log files are not available.The information indicated that this was not isolated to one patient, subsequent issues had occurred.The patient tracker did not move and the patient tracker cable was not under tension in relation to the event.There was no ferromagnetic material placed within the trudi zone.The emitter pad did not move and the patient did not move.There was no other device¿s shaft in the proximity to an emitter pad¿s transmitter.Related to the 0° trudi nav suction device (tdns000z / lot# unknown), when the accuracy issue was observed, the bar below the device icon on the trudi system monitor was green.There was no error message on the trudi nav monitor for this device.The device was plugged in after registration.Inaccuracy for the device was determined through visualization and endoscopic view instrumentation.The inaccuracy was not within 2mm.The lot number of the device is not available.Based on the additional information received on 24-apr-2024, the issues reported have been determined to be usfda reportable under 21 cfr 803 with a classification of ¿malfunction.¿.
|
|
Manufacturer¿s ref.No:(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section d.4: the trudi suction device does not have an expiration date; it is not a single use device.Trudi¿ suction instruments are supplied non-sterile and must be cleaned and sterilized prior to each usage.Section e.1: the name, phone and email address of the initial reporter are not available / reported.Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.Based on complaint information, the device is not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information available and without the complaint product available to be returned for analysis, the reported product issue documented in the complaint cannot be confirmed through functional evaluation and analysis.The lot number of the device is not known; therefore, manufacturing documentation review was not performed.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.This is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3005172759-2024-00037, 3005172759-2024-00038, and 3005172759-2024-00039.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by acclarent, or its employees that the report constitutes an admission that the product, acclarent, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
|
