MAUDE Adverse Event Report: ASPEN SURGICAL BARD-PARKER; BLADE SURG RIB BCK CARB 10

Model Number 371110

Device Problem Dull, Blunt (2407)

Patient Problem Insufficient Information (4580)

Event Date 10/14/2020

Event Type  malfunction  

Event Description

The 10 blade in packs were dull.Discovered during procedure, no delay to case, no harm to patient, but there was patient contact.The dull blades were contained within roi cps, llc custom pack (b)(4) (minor neuro) lot 79280ab.

• Brand Name: BARD-PARKER
• Type of Device: BLADE SURG RIB BCK CARB 10
• Manufacturer (Section D): ASPEN SURGICAL; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer (Section G): ASPEN SURGICAL; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: cheyenne stewart ; 3000 east sawyer road; republic, MO 65738 ; 4177303937
• MDR Report Key: 10733655
• MDR Text Key: 214652561
• Report Number: 3014527682-2020-00019
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 10/26/2020

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: 371110
• Device Lot Number: 0209336
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 10/26/2020
• Was Device Evaluated by Manufacturer?: No
• 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