MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. N/A; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, LAPAROSCOPIC ENDOSCOPIC

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
When using the ligasure the hand piece stopped working and the machine read the error: does not identify device (something similar).Dr.Stated this has happened before and they had to shut down the whole machine.A new hand piece was opened and the machine was shut off.It functioned properly after that.

• Brand Name: N/A
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, LAPAROSCOPIC ENDOSCOPIC
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 8835636
• Report Number: 8835636
• Device Sequence Number: 13983119
• Product Code: NUJ
• UDI-Device Identifier: 00885825017620
• UDI-Public: (01)00885825017620
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/01/2019
• Report Date (Section F): 07/01/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LF1637
• Device Lot Number: 10095393
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Weight: 129
• Date Report Sent to FDA: 07/01/2019