MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH POLARIS FO BLADE MILLER 2; LARYNGOSCOPE, RIGID

Catalog Number	4150020
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "polaris blade coating coming off during intubation." no patient injury or consequences reported.
Additional Manufacturer Narrative
(b)(4).The defective sample was returned to the manufacturer for evaluation.The manufacturer reported: an adhesion test (cross-cut test) was performed on retained samples of production batch ab2503044, and the result was 'passed'.Upon reviewing the dhr records of this batch, no such defects were found during routine inspection and random sampling.The sample had obvious surface scratches, with coating delamination at deeply scratched areas.Such scratches were generally caused by forced contact and friction with sharp metal objects.We performed a cross-cut test next to the coating delamination area of the sample, and the test result was acceptable.We didn't identify anything abnormal with the manufacturing process.However, we are unsure whether any collision occurred during transit.A full re-inspection was performed on the unshipped finished products (1 batch, totaling (b)(4) pcs).Subsequent random sampling by qc revealed no such defects.An internal meeting was arranged for all production operators and qc inspectors to highlight the risks of coating peeling.Meanwhile, relevant personnel were retrained on inspection procedures.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

• Brand Name: RUSCH POLARIS FO BLADE MILLER 2
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 25250219
• Report Number: 3011137372-2026-00160
• Device Sequence Number: 10623041
• Product Code: CCW
• UDI-Device Identifier: 14026704711762
• UDI-Public: (01)14026704711762(11)241229(17)280328(10)AB2503044(21)
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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 Catalogue Number: 4150020
• Device Lot Number: AB2503044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.
• Patient Sex: Unknown