MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. N/A; ELECTROSURGICAL, CUTTING & COAG, REPROCESSED

Model Number LF4418

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/22/2019

Event Type  No Answer Provided  

Event Description

Significant venous bleeding after taking the middle colic pedicle with reprocessed ligasure device.

• Brand Name: N/A
• Type of Device: ELECTROSURGICAL, CUTTING & COAG, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 9213347
• MDR Text Key: 163018388
• Report Number: 9213347
• Device Sequence Number: 1
• Product Code: NUJ
• 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: 10/02/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: LF4418
• Device Catalogue Number: LF4418
• Device Lot Number: 10424874
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2019
• Type of Device Usage: N
• Patient Sequence Number: 1