MAUDE Adverse Event Report: COVIDIEN LP SIGNIA LOADING UNIT; STAPLE, IMPLANTABLE

Model Number SIGLU60A

Device Problems Material Separation (1562); Separation Failure (2547)

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

Event Date 07/21/2022

Event Type  malfunction  

Event Description

The loading unit separated from the stapler shaft and become wobbly.The scrub tech was unable to separate the two pieces.

• Brand Name: SIGNIA LOADING UNIT
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 15174218
• MDR Text Key: 297338518
• Report Number: 15174218
• 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: 07/22/2022

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: SIGLU60A
• Device Lot Number: N1L0263Y
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14965 DA
• Patient Sex: Female