MAUDE Adverse Event Report: COVIDIEN; STAPLER, SURGICAL

Model Number EGIAUSHORT

Device Problems Break (1069); Failure to Advance (2524); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 05/28/2017

Event Type  malfunction  

Event Description

In the first attempt to squeeze the handle three times as required by manufacturer, it "broke".The handle would not advance and made a cracking noise.This was at a critical point in the surgery, and there was a delay for another stapler to be located and opened.

• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 6680753
• MDR Text Key: 78820701
• Report Number: 6680753
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2017

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: Physician
• Device Model Number: EGIAUSHORT
• Device Catalogue Number: EGIAUSHORT
• Device Lot Number: P7B0918X
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/02/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26 YR