MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC FIXED HEAD 35-COUNT SKIN STAPLER; STAPLER, SURGICAL

Catalog Number 25-3001

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 08/12/2020

Event Type  malfunction  

Event Description

While using the stapler to close the patient's surgical incision, multiple staples fell out of the staple gun onto the patient.

• Brand Name: FIXED HEAD 35-COUNT SKIN STAPLER
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC; 200 debusk lane; powell TN 37849
• MDR Report Key: 10436006
• MDR Text Key: 203825913
• Report Number: 10436006
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 25-3001
• Device Lot Number: 73B2000 290
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2020
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16060 DA