MAUDE Adverse Event Report: STERIS CORPORATION SNOWDEN-PENCER; DIAMOND-EDGES SCISSORS

Model Number	32-0709
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that a tip from their diamond-edges scissors broke off and fell into the patient; the scissor tip was retrieved.User facility personnel elected to perform an x-ray and confirmed no pieces from the scissors were present.The patient procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
Following the reported event, user facility personnel discarded the pair of diamond-edges scissors.As the device is not available for evaluation or return a root cause could not be determined.The device history record (dhr) was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.No additional issues have been reported.

• Brand Name: SNOWDEN-PENCER
• Common Device Name: DIAMOND-EDGES SCISSORS
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley rd; mentor OH 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: 20199988
• Report Number: 1527821-2024-00013
• Device Sequence Number: 7643427
• Product Code: LRW
• UDI-Device Identifier: 10885403145551
• UDI-Public: (01)10885403145551
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/12/2024

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: 32-0709
• Device Catalogue Number: 320709
• Device Lot Number: (10)C23XTA
• 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: 08/13/2024
• Initial Report FDA Received Date: 09/12/2024
• 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