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
Additional Manufacturer Narrative
This device was returned without its original packaging.Visual inspection as received condition found minor scratches, tiny dents on the distal tip and biomaterial inside the handle consistent with use.However, no other physical impact on the distal tip.The instrument is free of corrosion.Shaft is straight.The handle is firmly attached to the shaft, no looseness, no breakage or missing fragment.The reported complaint could not be determined since customer did not send in their trocar tube and sealing cap that had been used with the device.Also, the test instruments such as trocar tube wa58169s and sealing cap a5858 are not available in house at time of evaluation; therefore, the fitting could not be verified.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.This report has also been submitted on importer medwatch report # 24903-2023-00112.
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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 13 years since the subject device was manufactured.Based on the results of the investigation, the cause of the reported event is likely due to wear and tear of the device.However, it remains unclear if damage can be traced back to wear and tear only, or if mechanical force (impact, drop, etc.) was applied to the device.This supplemental report includes a correction to d4 and e3 from the initial medwatch.Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17012351
• Report Number: 9610773-2023-01458
• Device Sequence Number: 15370812
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2024

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
• Device Catalogue Number: WA58365S
• Device Lot Number: 108W-0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2010
• 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 Sex: Unknown