MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TROCAR SPIKE, 11 X 60 MM, BLUNT; WA58365S

Model Number	WA58365S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a thoracoscopy, the first thoracoscopy pan the physician opened was missing the 10 mm metal obturator for the metal trocar.A second pan was opened.Upon using the 10 mm trocar, when the physician went to move the obturator, only the plastic top of the obturator came out.The metal end of the obturator fell through the trocar into the patient¿s chest.It took the physician 45-60 minutes to find and remove the foreign metal object.Additional information has been requested but not received.

• Brand Name: TROCAR SPIKE, 11 X 60 MM, BLUNT
• Common Device Name: WA58365S
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 20445849
• Report Number: 2429304-2024-0000438
• Device Sequence Number: 8091328
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2024
• Report Date (Section F): 09/25/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/25/2024
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2024
• 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 Age: 67 YR
• Patient Sex: Male