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

Model Number 371110

Device Problem Dull, Blunt (2407)

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

Event Type  malfunction  

Event Description

Discovered during procedure, no delay to case, no harm to patient, but there was patient contact.Blades were dull in custom packs.The dull blades were contained within roi cps, llc custom pack 880151009 (surgi start) lot numbers 2003543811 and 2002944022.

• Brand Name: BARD-PARKER
• Type of Device: BLADE SURG RIB BCK BARB 10
• Manufacturer (Section D): ASPEN SURGICAL; 6945 southbelt dr se; caledonia, mi
• Manufacturer (Section G): ASPEN SURGICAL; 6945 southbelt dr se; caledonia, mi
• Manufacturer Contact: cheyenne stewart ; 3000 east sawyer road; republic, mo ; 7303937
• MDR Report Key: 10521351
• MDR Text Key: 231189370
• Report Number: 3014527682-2020-00013
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/11/2020

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 Catalogue Number: 371110
• Device Lot Number: 0209336 AND 0209798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 09/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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