MAUDE Adverse Event Report: COVIDIEN LP GIA; STAPLE, IMPLANTABLE

Model Number	030403
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During laparoscopic appendectomy, covidien gia universal stapler with 30mm tan load was passed through 12mm covidien versastep trocar.Unable to maintain insufflation with stapler in place, and we noticed small plastic shards fall into abdomen.These were photographed, removed and saved in a specimen cup.The trocar and stapler+reload were handed off the field and replaced with new equipment which was used to complete the case.We surveyed the abdomen laparoscopically and did not identify any additional pieces.

• Brand Name: GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8174190
• Report Number: 8174190
• Device Sequence Number: 1857423
• Product Code: GDW
• UDI-Device Identifier: 10884523003437
• UDI-Public: (01)10884523003437
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Type of Report: Initial
• Report Date (Section B): 12/12/2018
• Report Date (Section F): 12/12/2018

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
• Operator of Device: Health Professional
• Device Model Number: 030403
• Device Catalogue Number: 030403
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 12/12/2018