MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TROCAR SPIKE, 11 X 60 MM, BLUNT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	WA58365S
Medical Device Problem Code	Material Fragmentation (1261)
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
Olympus received a medwatch report (2301650000-2023-8005) through the mail which stating "while scrubbed into doctor's video-assisted thoracic surgery (vats) case and i handed him an 11mm trocar obturator.After he inserted it, he only handed me back a piece of plastic, instead of the obturator.The plastic was part of the obturator.The metal portion of the obturator was not returned to me, i informed him that i did not get it.On further examination, we found that the obturator came apart.They feel into the patient's chest cavity.The obturator was retrieved from the patient.The entire silver portion dropped into the body cavity; only the black handle was given to the scrub tech.".

• Brand Name: TROCAR SPIKE, 11 X 60 MM, BLUNT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrae 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 16885765
• Report Number: 2429304-2023-00090
• Device Sequence Number: 20414550
• 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): 05/08/2023
• Report Date (Section F): 04/07/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/07/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2023
• 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 Age: 56 YR
• Patient Sex: Male