MAUDE Adverse Event Report: STERIS CORPORATION V. MUELLER; HALSTED MOSQUITO FORCEPS

Model Number	SU2702
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure, the distal end broke on their halsted mosquito forceps.The distal end was successfully retrieved during a follow up procedure, and no injuries were reported.
Additional Manufacturer Narrative
The device subject of the reported event was discarded by user facility personnel and is not available for evaluation.Without the returned device, a root cause could not be determined.As the device was discarded and a lot number was not provided, a review of the device history record could not be performed.No additional issues have been reported.Udi related data clarification - the lot/serial number is unknown; therefore, the applicable production identifiers were not included in the mdr.

• Brand Name: V. MUELLER
• Common Device Name: HALSTED MOSQUITO FORCEPS
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley rd; mentor 44060
• Manufacturer (Section G): STERIS CORPORATION; 5960 heisley rd; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 22036222
• Report Number: 1527821-2025-00007
• Device Sequence Number: 20868492
• Product Code: GEN
• UDI-Device Identifier: 10885403064012
• UDI-Public: (01)10885403064012
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2025

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: SU2702
• Device Catalogue Number: SU2702
• 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: 04/16/2025
• Initial Report FDA Received Date: 05/16/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown