MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. CONTOUR; STAPLER, SURGICAL

Model Number CS40G

Device Problems Break (1069); Failure to Fire (2610)

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

Event Date 11/08/2017

Event Type  malfunction  

Event Description

Early evening, attending surgeon using contour curved cutter stapler, stapler handle broke.Broken handle piece retrieved and pieces match.Contour handle did not fire per attending report.No pieces of instrument identified in abdominal incision- midline per attending report.Twenty seven minutes later, an x-ray completed of all four quadrants of abdomen.At seven minutes after that attending radiologist (b)(6) spoke with attending in room.An x-ray of all four quadrants negative.No foreign bodies identified on x-ray.

• Brand Name: CONTOUR
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek rd.; ml 120a; cincinnati OH 45242
• MDR Report Key: 7048074
• MDR Text Key: 92625241
• Report Number: 7048074
• 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: 11/10/2017

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 Expiration Date: 07/31/2022
• Device Model Number: CS40G
• Device Lot Number: P9397C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/10/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR