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

Model Number GIA8038S

Device Problems Mechanical Problem (1384); Retraction Problem (1536)

Patient Problem Insufficient Information (4580)

Event Date 04/27/2023

Event Type  malfunction  

Event Description

Using a gia 80mm for a small bowel resection, the blade got stuck halfway down the load upon retraction of firing the device when completing the anastomosis.Tried to retract the blade to unload but wouldn't retract.Had to open tlc stapler.

• Brand Name: GIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 17019205
• MDR Text Key: 316109775
• Report Number: 17019205
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/17/2023,05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIA8038S
• Device Lot Number: P1M0653
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 7665 DA
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: Black Or African American