MAUDE Adverse Event Report: ASPEN SURGICAL BARD PARKER; BLADE SURG RIB BCK CARB 15 BLADE

Model Number 371115

Device Problem Break (1069)

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

Event Date 01/04/2022

Event Type  malfunction  

Event Description

The 15 blade snapped in half when removing from handle.There was patient contact, but the blade snapped once the procedure was finished.There was no harm to patient.

Manufacturer Narrative

The 15 blade is a component contained within roi cps, llc convenience kit 880118, lot 90086.

• Brand Name: BARD PARKER
• Type of Device: BLADE SURG RIB BCK CARB 15 BLADE
• Manufacturer (Section D): ASPEN SURGICAL; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): ROI CPS, LLC; 3000 east sawyer road; republic MO 65738
• Manufacturer Contact: cheyenne stewart ; 3000 east sawyer road; republic, MO 65738 ; 4176473205
• MDR Report Key: 13334456
• MDR Text Key: 294402912
• Report Number: 3014527682-2022-00001
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 371115
• Device Catalogue Number: 371115
• Device Lot Number: 260152
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2022
• 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