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 (b)(4) 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.".
Additional Manufacturer Narrative
The device has not been returned to olympus for evaluation.The investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.

• 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
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16879835
• Report Number: 9610773-2023-01226
• Device Sequence Number: 7261750
• Product Code: GCJ
• UDI-Device Identifier: 04042761030779
• UDI-Public: 04042761030779
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K923982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2023

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male