MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ETHICON ENDO-SURGERY STAPLER REGULAR STAPLER 35 FIXED HEAD; STAPLE, REMOVABLE (SKIN)

Model Number ITM

Device Problems Device Slipped (1584); Failure to Form Staple (2579)

Patient Problem Insufficient Information (4580)

Event Date 03/04/2023

Event Type  malfunction  

Event Description

During appendectomy- skin stapler allowed staples to pop out of skin easily, requiring another stapler to be used.Normal skin stapler is on back-order and temporary replacement product provided that failed is: (b)(4) stapler 35 skin fixed head reg ethicon endo-surgery stapler ref # pmr 35.Supplier (b)(4) lot # 116c83.After cleaning blood from the abdomen, 3 staples popped out of the incisions requiring replacement staples and placing bandaids on the wounds.The skin stapler was disposed of post surgery.

• Brand Name: ETHICON ENDO-SURGERY STAPLER REGULAR STAPLER 35 FIXED HEAD
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.
• MDR Report Key: 16771014
• MDR Text Key: 313658619
• Report Number: MW5116826
• Device Sequence Number: 1
• Product Code: GDT
• 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: 04/14/2023

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: ITM
• Device Catalogue Number: PMR 35
• Device Lot Number: 116C83
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Sex: Male
• Patient Weight: 104 KG