MAUDE Adverse Event Report: MEDTRONIC; STAPLER, SURGICAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abscess (1690); Fever (1858); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 04/16/2019

Event Type  Injury  

Event Description

Patient arrived to the or for a planned laparoscopic low anterior bowel resection and a laparoscopic loop ileostomy.4 days later: to ir for a ct-guided placement of a percutaneous pelvic drains for llq abscesses.3 days later: to or for exploratory lap with abd.Washout, abscess drainage, takedown of disrupted colorectal anastomosis with colostomy creation.Complete breakdown of anastomosis.1 day later: to icu secondary to tachycardia, fever, hypotension for a levophed drip.1 day later: to ir for drainage of abscess.Approximately 2 weeks later: pt.Discharged to ltach.Patient is still hospitalized there.

• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): MEDTRONIC; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8707253
• MDR Text Key: 148279271
• Report Number: 8707253
• 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: 22630 DA
• Patient Weight: 102