MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. TROCAR INTRODUCER

Model Number	MAJ-1379
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
The customer reported to olympus, near the end of the therapeutic laparoscopy, part of the subject device was damaged.The subject device was attached to olympus endoscope ltf-s190-5 and used as an insertion aid.A portable x-ray did not confirm any debris in abdominal cavity, no shadows seen.After the procedure was completed, a ct scan confirmed pieces fell into the abdominal cavity.A reoperation was performed (b)(6) 2022 and the foreign material was removed.It is unclear when c0r47 was used by the customer.The patient was discharged without further issues (b)(6) 2022.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide a correction, additional information from the customer, and the results of the device evaluation, legal manufacturer¿s investigation and the device history record (dhr) review.New information was added to the following fields: b5, d9, h3, h6, h10.Correction: e1 - hayata is the contact's last name only.The device was returned to olympus for evaluation and the customer's allegation was confirmed.Inspection of the device found the broken part was not part of the hook but was part of the holding parts at the opposite side.As a result of inspection of the fractured surface, a wavy pattern which was typical to fatigue failure was noted.The device history records (dhr) for this device could not be reviewed since the lot number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to the combined effect of stress by the repeated use and stress.However, the cause of breakage was not specified since no more analysis with the actual device was available.Olympus will continue to monitor the field performance of the device.
Event or Problem Description
Additional information was received from the customer: the foreign material was removed from the abdominal cavity on (b)(4) 2022, using a laparoscope and grasping forceps under general anesthesia.The device information for the laparoscope and grasping forceps is unknown.

• Brand Name: TROCAR INTRODUCER
• Common Device Name: TROCAR INTRODUCER
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15106218
• Report Number: 9610595-2022-00302
• Device Sequence Number: 12055693
• Product Code: GCJ
• UDI-Device Identifier: 04953170316159
• UDI-Public: 04953170316159
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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: MAJ-1379
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/26/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LTF-S190-5(2824359).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown