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

Model Number 371215

Device Problems Material Discolored (1170); Structural Problem (2506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2021

Event Type  malfunction  

Event 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
• Type of Device: BLADE 15 SHRP KNF BP SS TISS SURG
• Manufacturer (Section D): ASPEN SURGICAL; 6945 southbelt dr.; caledonia MI 49316
• Manufacturer (Section G): ASPEN SURGICAL; 6945 southbelt dr.; caledonia MI 49316
• Manufacturer Contact: cheyenne stewart ; 3000 east sawyer road; republic, MO 65738 ; 4176473205
• MDR Report Key: 12094392
• MDR Text Key: 263106337
• Report Number: 3014527682-2021-00012
• Device Sequence Number: 1
• Product Code: GES
• UDI-Device Identifier: 00840113204380
• UDI-Public: 00840113204380
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 371215
• Device Catalogue Number: 371215
• Device Lot Number: 0240091
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1