MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TROCAR SPIKE, 11 X 60 MM, BLUNT; TROCAR SPIKES (THORACOSCOPY, LAPAROSCOPY)

Model Number	WA58365S
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
Health Effect - Clinical Codes	No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Event or Problem Description
Olympus was informed that during an unspecified thoracoscopy procedure, when inserting the trocar, the mandrel of the trocar spike broke and the rod slid along the trocar sleeve to protrude into the thorax.The surgeon managed to recover the metal rod but the operation/anesthesia was prolonged as a result.No further information was provided.
Additional Manufacturer Narrative
The suspect medical device was returned to the manufacturer for investigation.The investigation confirmed that the handle of the trocar spike is broken off.The cause of this damage is most likely wear and tear due to heavy use.The product is designed for 400 uses and reprocessing cycles, which have probably been exceeded.Therefore, this event/incident was attributed to use error.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the trocar without showing any abnormalities.The case will be closed from olympus side with no further actions but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results.

• Brand Name: TROCAR SPIKE, 11 X 60 MM, BLUNT
• Common Device Name: TROCAR SPIKES (THORACOSCOPY, LAPAROSCOPY)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 11228549
• Report Number: 9610773-2021-00055
• Device Sequence Number: 3556746
• Product Code: GCJ
• UDI-Device Identifier: 04042761030779
• UDI-Public: 04042761030779
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: company representative,distri
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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: 112W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 03/12/2021
• 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: 37 YR