MAUDE Adverse Event Report: MCKESSON MEDICAL-SURGICAL INC. MCKESSON; STERILANT

Model Number	73-OPA28
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mckesson opa/28 hld safety data sheet states, "may cause skin irritation.Symptoms may include redness, drying, defatting and cracking of the skin.May produce an allergic skin reaction." the mckesson opa/28 hld instructions for use states, "containdications 1.Mckesson opa/28 should not be used to reprocess any urological instrumentation to be utilized for cystoscopy or other urological procedures for patients with a history of bladder cancer.In rare instances similar ortho-phthalaldehyde (opa) based disinfectants have been associated with anaphylaxis-like reactions in bladder cancer patients undergoing repeated cystoscopies." steris was notified of the reported event by the distributor.The distributor made multiple attempts to obtain additional information regarding the reported events from the user facility; however, additional information was not provided.The distributor has offered in-service training on the proper use and operation of the mckesson opa/28 hld, specifically on use during cystoscopies.No additional issues have been reported.
Event or Problem Description
The user facility reported that five different patients experienced allergy symptoms following procedures which included use of cystoscopes reprocessed using mckesson opa/28 hld.The patients sought additional medical treatment; however, it is unknown if medical treatment was administered.

• Brand Name: MCKESSON
• Common Device Name: STERILANT
• Manufacturer (Section D): MCKESSON MEDICAL-SURGICAL INC.; 9954 maryland drive; suite 4000; richmond VA 23233
• Manufacturer (Section G): MCKESSON MEDICAL-SURGICAL INC.; 9954 maryland drive; richmond VA 23223
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 25183096
• Report Number: 2150060-2026-00020
• Device Sequence Number: 18817009
• Product Code: MED
• UDI-Device Identifier: 10612479185989
• UDI-Public: (01)10612479185989
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 05/15/2026

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: 73-OPA28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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