MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L ESOPH STETH 400 SERIES 9 FR; STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS

Model Number	81-040409
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Date of Event	01/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complaint was found in the literature source "the oropharyngeal bleeding after esophageal stethscope insertion" from the journel anesthesia and pain medicine reporting, "prior to surgery vitals were normal.When the patient entered the surgical room a deroyal esophageal stethoscope was placed following anesthesia.Slight resistance was observed at the oropharynx but overall, the insertion was not very difficult.Surg-jelle was used as a lubricant to ease insertion.The esophageal stethoscope was placed to 30cm from the upper lip and secured once no strangulation or bleeding on the oral cavity was confirmed.After 2hr 25 mins of surgery the stethoscope was removed, and red blood was observed on the tip of the stethoscope.No blood was found during endotracheal suction.A small amount of blood was found during intraoral suction.There was no visible blood on the tracheal tube once removed.During post op the patient intermittently coughed an insignificant amount of blood which decreased over time.The patient was released to the general ward but continued to have unclear complaints the patient began coughing out bloody sputum and his bp dropped.$ hours and 30 mins post op a l tube was inserted, and irrigation presented bloody.The laryngoscopic examination led to the identification of a linear laceration (1cm wide by 1-2 mm deep).The laceration was addressed, and hemostasis was achieved with epinephrine/lidocaine gauze.Bp normalized and the patient was discharged 19 days post op with no other incidents.Total blood in sputum on day 1 of post op was less than 1 liter.Patient follow up 3 months later, esophagogastroduodenoscopy showed no problem but atrophic gastritis with the possibility of esophageal varix bleeding to be very low." deroyal pulled complaint information from 2018 to present and found that a total of 525 000 eaches of part number 81-040409 had been sold and within that time frame there were 2 complaints generated.This represents a complaint/sales ratio of (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
Prior to surgery vitals were normal.When the patient entered the surgical room a deroyal esophageal stethoscope was placed following anesthesia.Slight resistance was observed at the oropharynx but overall, the insertion was not very difficult.Surg-jelle was used as a lubricant to ease insertion.The esophageal stethoscope was placed to 30cm from the upper lip and secured once no strangulation or bleeding on the oral cavity was confirmed.After 2hr 25 mins of surgery the stethoscope was removed, and red blood was observed on the tip of the stethoscope.No blood was found during endotracheal suction.A small amount of blood was found during intraoral suction.There was no visible blood on the tracheal tube once removed.During post op the patient intermittently coughed an insignificant amount of blood which decreased over time.The patient was released to the general ward but continued to have unclear complaints the patient began coughing out bloody sputum and his bp dropped.$ hours and 30 mins post op a l tube was inserted, and irrigation presented bloody.The laryngoscopic examination led to the identification of a linear laceration (1cm wide by 1-2 mm deep).The laceration was addressed, and hemostasis was achieved with epinephrine/lidocaine gauze.Bp normalized and the patient was discharged 19 days post op with no other incidents.Total blood in sputum on day 1 of post op was less than 1 liter.Patient follow up 3 months later, esophagogastroduodenoscopy showed no problem but atrophic gastritis with the possibility of esophageal varix bleeding to be very low.

• Brand Name: ESOPH STETH 400 SERIES 9 FR
• 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: 19929635
• Report Number: 9613793-2023-00001
• Device Sequence Number: 2760609
• Product Code: BZT
• UDI-Device Identifier: 00749756046008
• UDI-Public: 00749756046008
• 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: 81-040409
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• 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