MAUDE Adverse Event Report: TRACOE MEDICAL GMBH TRACOE TWIST PLUS TRACHEOSTOMY SPARE CANNULA

Model Number	REF 521-09
Medical Device Problem Codes	Use of Device Problem (1670); Device Stenosis (4066)
Health Effect - Clinical Code	Respiratory Failure (2484)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2026 the patient experienced a drop in oxygen saturation and could not be suctioned endotracheally.The lower part of the cannula had torn, and the ends had curled inward.This blocked the suction path.A bronchoscopy was performed, the cannula was replaced, and ventilation resumed without issues.
Additional Manufacturer Narrative
According to the complaint description the patient experienced a drop in oxygen saturation and could not be suctioned endotracheally.The lower part of the inner cannula had torn, and the ends had curled inward.This blocked the suction path.Detected after 1 week of use & regularly cleaning.The defect could be verified at the received sample: the inner cannula tip is dented inward by half (without a crack) and the outer rim shows little notches.It seems as if the tip of the inner cannula was pressed against a punctual resistance with force.Therefore, as the defect was detected after one week of use with regular cleaning and not in the beginning, it can be assumed that a handling at user's side led to the defect.Nevertheless, the cause cannot be conclusively determined as no batch record and production data review is possible due to the missing lot.

• Brand Name: TRACOE TWIST PLUS TRACHEOSTOMY SPARE CANNULA
• Common Device Name: TRACOE TWIST PLUS TRACHEOSTOMY SPARE CANNULA
• Manufacturer (Section D): TRACOE MEDICAL GMBH; reichelsheimer str. 1/3; nieder-olm, 55268 ; GM 55268
• Manufacturer (Section G): TRACOE MEDICAL GMBH; reichelsheimer str. 1/3; nieder-olm, 55268 ; GM 55268
• Manufacturer Contact: margarete halle ; reichelsheimer str. 1/3; nieder-olm, 55268 ; GM 55268
• MDR Report Key: 25079696
• Report Number: 8010485-2026-71606
• Device Sequence Number: 10418819
• Product Code: JOH
• UDI-Device Identifier: 04035324018215
• UDI-Public: 4035324018215
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K961449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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: REF 521-09
• Device Catalogue Number: REF 521-09
• Device Lot Number: N.A.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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