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

Model Number SIGPSHELL

Device Problems Defective Component (2292); Device Sensing Problem (2917)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2019

Event Type  malfunction  

Event Description

Battery was not recognized by shell, alert stating shell was defective.

• Brand Name: SIGNIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8792869
• MDR Text Key: 151113803
• Report Number: 8792869
• 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: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SIGPSHELL
• Device Catalogue Number: SIGPSHELL
• Device Lot Number: N9A0844UY
• 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: 07/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7300 DA