MAUDE Adverse Event Report: US ENDOSCOPY TRUFREEZE; RAPID AV CATHETER

Model Number	2000516
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris received confirmation from user facility personnel that the catheter subject of the reported event was not utilized in a patient procedure and was observed to be broken when the user opened the package.User facility personnel confirmed no other catheters were broken from the same box or from the same lot number.The instructions for use states, "do not use the product if the device does not function properly or there is evidence of damage (e.G.Kinks, bends or damaged packaging).Save the device and packaging and contact your local steris endoscopy product specialist." the catheter subject of the reported event was returned to steris for evaluation.Evaluation results found that the catheter shaft was broken from the proximal end of the bayonet.The observed breakage as stated in the reported event appeared to be a clean break through the hypo tube.Steris evaluated the reported event and determined it does not meet our reporting criteria under 21 cfr part 803.It should be noted that steris is submitting a medical device report (mdr) solely due to the receipt of the user facility medwatch report which is in accordance with our procedures and policies.The device history record was reviewed and confirmed the subject lot was manufactured to specifications; no abnormalities were noted.A complaint review was performed and confirmed the reported event to be isolated for the subject lot.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch (b)(4) that, "prepping for cryo case, trufreeze catheter came broken in package and had to be replaced.Technician noted prior to use that the white catheter section was broken from the black section".No report of injury.

• Brand Name: TRUFREEZE
• Common Device Name: RAPID AV CATHETER
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 24831399
• Report Number: 1528319-2026-00028
• Device Sequence Number: 10220296
• Product Code: GEH
• UDI-Device Identifier: 00724995199326
• UDI-Public: (01)00724995199326(11)250701(17)270701(10)5519
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K223369
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2026

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: 2000516
• Device Catalogue Number: 2000516
• Device Lot Number: (10)5519
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2025
• 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