MAUDE Adverse Event Report: COVIDIEN LP GIA STAPLER WITH DST SERIES TECHNOLOGY; STAPLE, IMPLANTABLE

Model Number GIA8038S

Device Problems Mechanical Problem (1384); Misfire (2532)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2022

Event Type  malfunction  

Event Description

The patient was having a bowel resection for an intrabdominal abscess.The physician was using a gia 80mm stapler.The stapler misfired.Another gia 80mm stapler was used- this time the blade fired but the stapler did not.This resulted in the physician having to remove 5-10cm of the bowel.The patient was discharged.The physician reports that the patient was discharged in good clinical condition.Both staplers are from the same lot number.

• Brand Name: GIA STAPLER WITH DST SERIES TECHNOLOGY
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 15319425
• MDR Text Key: 298876252
• Report Number: 15319425
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIA8038S
• Device Catalogue Number: GIA8038S
• Device Lot Number: P2D0251
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27010 DA
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Race: White