MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS STRYKER BLADELESS TROCAR & SLEEVE; LAPAROSCOPE, GENERAL PLASTIC SURGERY, REPROCESSED

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was taken to the operating room.General anesthesia was induced; patient was prepped and draped in a standard sterile fashion.Surgeon then proceeded to do a laparoscopic appendectomy.Towards the end of the surgery, surgeon attempted to remove the trocar from the sleeve.The outer end of the trocar just broke and crumbled into pieces.No harm done to the patient.Manufacturer response for laparoscope, general plastic surgery, reprocessed, n/a (per site reporter).Device is with surgery inventory coordinator in materials management department.

• Brand Name: STRYKER BLADELESS TROCAR & SLEEVE
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 8797961
• Report Number: 8797961
• Device Sequence Number: 2484798
• Product Code: NLM
• UDI-Device Identifier: 00885825017248
• UDI-Public: (01)00885825017248(17)200325(10)10069032
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/26/2019
• Report Date (Section F): 06/26/2019

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: 2B5LT
• Device Lot Number: 10069032
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Weight: 59
• Date Report Sent to FDA: 06/26/2019