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

Model Number	N/A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The insulation coating, from the stryker sustainability solutions endopath 5mm endoscopic reprocessed scissor, peeled back at apex where hinge and closing mechanism on scissor come together.

• Brand Name: N/A
• Common Device Name: ELECTROSURGICAL, CUTTING, COAGULATION, LAPAROSCOPIC ENDOSCOPIC
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 west drake dr; tempe AZ 85283
• MDR Report Key: 14188408
• Report Number: 14188408
• Device Sequence Number: 11863704
• Product Code: NUJ
• UDI-Device Identifier: 00885825013288
• UDI-Public: (01)00885825013288
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2022
• Report Date (Section F): 04/12/2022

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: 5DCS
• Device Lot Number: 13363284
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 04/22/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 131 KG
• Patient Race: White
• Date Report Sent to FDA: 04/12/2022