MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L ESOPH STETH 400 SERIES 18 FR, 400 SERIES; STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS

Model Number	81-040418
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complaint was found in the literature source "arytenoid dislocation after uneventful endotracheal intubation: a case report" from the journal called korean j anesthesiol reporting, "on the first postoperative day in the ward, she complained of moderate hoarseness.The physician expected the symptom would resolve spontaneously, but the patient complained of persistent hoarseness on the fourth day after the operation.There were no symptoms other than hoarseness.On the sixth day after the operation, fiber-optic laryngoscopy was performed by the laryngologist.On laryngoscopy, the left vocal cord was fixed in the paramedian position, however minimal movement of arytenoid during phonation was observed.Arytenoid dislocation was suspected, and surgical reduction under general anesthesia was performed.The patient's voice was improved immediately after the surgery; and a month after the surgery, movement of the vocal cords was completely normal." (b)(4).The failure mode effect analysis (fmea) was reviewed and updated to reflect this risk.Deroyal also reviewed the material review report (mrr's) and it was confirmed that there were no other mrr's related to this product under investigation.This complaint was found in literature and no contact information was provided therefore no follow-ups were able to be conducted due to the source.While no specific corrective or preventative actions were taken, deroyal will continue to monitor for trends around this issue.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Event or Problem Description
On the first postoperative day in the ward, she complained of moderate hoarseness.The physician expected the symptom would resolve spontaneously, but the patient complained of persistent hoarseness on the fourth day after the operation.There were no symptoms other than hoarseness.On the sixth day after the operation, fiber-optic laryngoscopy was performed by the laryngologist.On laryngoscopy, the left vocal cord was fixed in the paramedian position, however minimal movement of arytenoid during phonation was observed.Arytenoid dislocation was suspected, and surgical reduction under general anesthesia was performed.The patient's voice was improved immediately after the surgery; and a month after the surgery, movement of the vocal cords was completely normal.

• Brand Name: ESOPH STETH 400 SERIES 18 FR, 400 SERIES
• Common Device Name: STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L; global park, p.o. box 180-3006; 602 parkway,; la aurora, heredia 146 ; CS 146
• Manufacturer (Section G): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L; global park, p.o. box 180-3006; 602 parkway,; la aurora, heredia 146 ; CS 146
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19929636
• Report Number: 9613793-2023-00002
• Device Sequence Number: 16834354
• Product Code: BZT
• UDI-Device Identifier: 00749756045988
• UDI-Public: 00749756045988
• Combination Product (Y/N): N
• PMA/510(K) Number: K193027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 81-040418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown