MAUDE Adverse Event Report: ASPEN SURGICAL BARD-PARKER STAINLESS STEEL BLADES; BLADE 15 SHRP KNF BP SS TISS SURG

Model Number	371215
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Blade package was opened during pre-surgical set up when scrub tech noticed ragged cutting edge and discoloration of blade.

• Brand Name: BARD-PARKER STAINLESS STEEL BLADES
• Common Device Name: BLADE 15 SHRP KNF BP SS TISS SURG
• Manufacturer (Section D): ASPEN SURGICAL; 6945 southbelt dr.; caledonia MI 49316
• MDR Report Key: 12094392
• Report Number: 3014527682-2021-00012
• Device Sequence Number: 16850296
• Product Code: GES
• UDI-Device Identifier: 00840113204380
• UDI-Public: 00840113204380
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2021

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: 371215
• Device Catalogue Number: 371215
• Device Lot Number: 0240091
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1