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

Model Number 030449

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Date 01/29/2021

Event Type  malfunction  

Event Description

During the procedure, several staple loads were used with the endo gia stapler.These loads included purple 45mm reloads and black 45mm reloads.A small piece of the yellow plastic guard that the reloads are packaged with was located within the chest cavity, immediately following the use of a reload.The surgeon successfully removed this piece.The size of the broken piece was roughly 1-2mm.The guard was removed prior to the load being inserted in the patient, therefore the team was unaware of how the piece ended up breaking and entering the chest cavity.Unsure whether it was user error or malfunction of equipment.

• Brand Name: ENDO GIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11444437
• MDR Text Key: 238630528
• Report Number: 11444437
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 030449
• Device Catalogue Number: 030449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/18/2021
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Weight: 77