MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L ESOPH STETH 400 SERIES 12 FR; STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS

Model Number	81-040412
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported, "temperature is rising and dropping, for example from 36 degrees, down to 31 degrees suddenly.Before returning to 36 degrees. ".
Additional Manufacturer Narrative
A user facility reported, "temperature is rising and dropping, for example from 36 degrees, down to 31 degrees suddenly.Before returning to 36 degrees." deroyal industries, inc.Requested return of the device, but it was unavailable for return.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report when additional information becomes available.
Additional Manufacturer Narrative
A user facility reported, "temperature is rising and dropping, for example from 36 degrees, down to 31 degrees suddenly.Before returning to 36 degrees." deroyal industries, inc.Requested return of the device, but it was unavailable for return.The device history record was reviewed and it was confirmed that no issues were identified in the assembly process.Using samples returned from other similar complaints, functional and dimensional testing was conducted that determined there was an instability at the connector side.Through further investigation, it was determined that a crimp set differed between the older molex machine and new automatic machine.Because of this difference, there was more pressure applied that caused the pin to deform in some cases.It was determined that this is what led to the connector instability.A complaint to sales ratio was conducted over the past two years and found to be (b)(4).Root cause: the root cause of the issue was the use of factory-installed crimp sets in the automatic machines with a pressing surface width narrower than the pin width.This dimensional incompatibility generated excessive localized mechanical stress during crimping, resulting in pin deformation, altered electrical contact geometry, and subsequent connector instability under temperature conditions.Immediate corrections: considering that the identified root cause was connector instability caused by insufficient electrical contact between the wire and the pin, all personnel involved were instructed to incorporate an additional verification step during functional testing.This step consists of gently manipulating the connector by moving it slightly once in an upward and downward direction and from side to side, in order to detect any potential intermittent or unstable conditions.Additionally, the sampling plan applied by quality control was escalated from normal inspection to tightened inspection.As a result, the sample size per box (2,000 units per box) was increased from 20 units to 32 units.This adjustment was implemented to strengthen detection capability, increase process oversight, and reduce the risk of escaping unstable units during the containment phase.Corrective actions: the automatic machine manufacturer (kingsing) and the local tool manufacturer (motrosa) were contacted.A dimensional modification of all automatic machine crimp sets was requested.Post implementation of these dimensional modifications indicate a substantial reduction in the instability rates.Deroyal will continue to monitor for trends around this item and issue.The 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.

• Brand Name: ESOPH STETH 400 SERIES 12 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 facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 23943868
• Report Number: 9613793-2025-00014
• Device Sequence Number: 13424136
• Product Code: BZT
• UDI-Device Identifier: 50749756045990
• UDI-Public: 50749756045990
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K193027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 81-040412
• Device Lot Number: 61840732
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 03/02/2026
• 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
• Patient Sex: Unknown