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

Model Number 371110

Device Problem Dull, Blunt (2407)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2020

Event Type  malfunction  

Event Description

Event discovered during procedure and involved patient contact.10 blades in at least 3 main or packs are dull.The dull blades were contained within roi cps, llc custom procedure pack 880011, lot 78068.

Event Description

Event discovered during procedure and involved patient contact.10 blades in at least 3 main or packs are dull.The dull blades were contained within roi cps, llc custom procedure pack 880011, lot 78068.

• Brand Name: BARD-PARKER
• Type of Device: BLADE SURG RIB BCK CARB 10
• Manufacturer (Section D): ASPEN SURGICAL; 6945 southbelt dr.; caledonia, mi
• MDR Report Key: 10260731
• MDR Text Key: 200048358
• Report Number: 3014527682-2020-00008
• 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: user facility
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/10/2020

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: 06/17/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 06/17/2020
• Supplement Dates FDA Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1