MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TROCAR SPIKE, 11 X 60 MM, BLUNT; LAPAROSCOPIC TROCAR BLADE, REUSABLE

Model Number	WA58365S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus that during a therapeutic thoracic surgery, this laparoscopic trocar blade came apart and fell into the patient's chest cavity.The obturator was retrieved from the patient.The procedure was completed.There were no reports of patient or user harm associated with this event.

• Brand Name: TROCAR SPIKE, 11 X 60 MM, BLUNT
• Common Device Name: LAPAROSCOPIC TROCAR BLADE, REUSABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 17012071
• Report Number: 2429304-2023-00112
• Device Sequence Number: 7538557
• Product Code: GCJ
• UDI-Device Identifier: 04042761030779
• UDI-Public: 04042761030779
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2023
• Report Date (Section F): 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA58365S
• Device Catalogue Number: WA58365S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown