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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Abdominal Distention (2601); No Code Available (3191)

Event Date 02/07/2019

Event Type  Injury  

Event Description

Patient arrived to the operating room for a planned robotic-assisted right colectomy.3 days later: patient not feeling well (nausea and bloated).4 days later: to or for exploratory lap with ileocolic resection and creation of end ileostomy.A distinct spot was found with some peritoneal exudate right in the middle of the medtronic ta staple line.5 days later: patient discharged to rehab.

• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek rd.; cincinnati OH 45242
• MDR Report Key: 8707296
• MDR Text Key: 148326974
• Report Number: 8707296
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/14/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 31755 DA
• Patient Weight: 56