MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD - PARKER SIZE 10 STAINLESS STEEL SURGICAL BLADE

Lot Number 0149935

Device Problem Break (1069)

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

Event Date 05/10/2018

Event Type  malfunction  

Event Description

While surgeon was performing a vaginal hysterectomy on a pt, a size 10 blade broke at the scalpel. All pieces were retrieved and placed in a sterile container. Retained in risk mgmt per organizational policy.

• Brand Name: BARD - PARKER
• Type of Device: SIZE 10 STAINLESS STEEL SURGICAL BLADE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.
• MDR Report Key: 7681204
• MDR Text Key: 113908568
• Report Number: MW5078330
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/25/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Lot Number: 0149935
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage