MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH SUCTION/IRRIGATION TUBE, 5.3 X 360 MM, BUTTON, UNIPOLAR, FOR HIQ+ HANDLE; SUCTIONIRRIGATION SYSTEM (HANDLE, VALVE TUBING, SUCTIONIRRIGATION TUBE)

Model Number	WA51138A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the user's experience 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 a laparoscopic gastrectomy procedure, a black plastic-like foreign body about 1 mm in size was found in the patient¿s abdominal cavity while the organs were being washed with a water supply suction tube.It is suspected that the black material comes from the black handle of the suction/irrigation tube (wa51138a) since it was found to be slightly scraped.However, the fragment was retrieved, and the intended procedure was successfully completed with the same set of equipment and there was no report of an adverse event or patient injury.
Additional Manufacturer Narrative
The suspect medical device and all concomitant devices were not returned to the manufacturer for investigation/evaluation but to olympus medical system corporation in hinode, japan (omsc) (returned to omsc on 2022/10/04).The investigation confirmed scratches and mark of contacts with a metallic device on the insulation of the valve, scratches on the suction irrigation tube and some broken fragments at the handle.These damages are attributed to use error.However, the investigation confirmed that the fragments found during the investigation and the fragments found during the procedure are not related to each other.It has been excluded the fragments found during the procedure are related to the olympus products involved.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of all involved devices without showing any abnormalities.The case will be closed on olympus side with no further actions and the user will be informed about the investigation results.

• Brand Name: SUCTION/IRRIGATION TUBE, 5.3 X 360 MM, BUTTON, UNIPOLAR, FOR HIQ+ HANDLE
• Common Device Name: SUCTIONIRRIGATION SYSTEM (HANDLE, VALVE TUBING, SUCTIONIRRIGATION TUBE)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 15657421
• Report Number: 9610773-2022-00497
• Device Sequence Number: 6463420
• Product Code: GCJ
• UDI-Device Identifier: 04042761024341
• UDI-Public: 04042761024341
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA51138A
• Device Catalogue Number: WA51138A
• Device Lot Number: 20422-0001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2022
• Supplement Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS HANDLE "HIQ+" (WA51172A); OLYMPUS VALVE TUBE, FOR HIQ+ HANDLE (WA51181L)
• Patient Sex: Unknown