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

Model Number N/A

Patient Problem Insufficient Information (4580)

Event Date 08/22/2023

Event Type  malfunction  

Event Description

While doing a colon resection, it was noticed that the plastic insulation at the tip of the stryker scissors was peeling off leaving exposed metal, no sparks were seen.

• Brand Name: N/A
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, LAPAROSCOPIC ENDOSCOPIC
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 18208838
• MDR Text Key: 328999367
• Report Number: 18208838
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 00885825013288
• UDI-Public: (01)00885825013288(17)260711(10)15085922
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2023

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
• Device Model Number: N/A
• Device Catalogue Number: 5DCS
• Device Lot Number: 15085922
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2023
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/27/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Sex: Male