MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VALVE TUBE, FOR HIQ+ HANDLE, SUCTION CHANNEL 8 MM, 1 PCS.; SUCTIONIRRIGATION SYSTEM (HANDLE, VALVE TUBING, SUCTIONIRRIGATION TUBE)

Model Number	WA51181L
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2019
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 after an unspecified therapeutic procedure, it was noticed that the irrigation connector of the valve tubing was damaged and that fragments had broken off.It is unknown when this damage occurred and whether any fragments were possibly flushed into the patient's body cavity.However, the intended procedure was successfully completed with the same set of equipment and there was no adverse event or patient injury.
Additional Manufacturer Narrative
Device evaluation: the suspect medical device was not returned to the manufacturer for investigation but to olympus medical systems corporation (omsc), japan (returned to omsc on 2019-07-02).The evaluation/investigation confirmed that the irrigation connector of the valve tubing is damaged and that a fragment has broken off.The cause of this damage is mechanical overload by the application of excessive force in combination with wear and tear.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 valve tube 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 and retrained to correctly use the olympus medical devices.

• Brand Name: VALVE TUBE, FOR HIQ+ HANDLE, SUCTION CHANNEL 8 MM, 1 PCS.
• Common Device Name: SUCTIONIRRIGATION SYSTEM (HANDLE, VALVE TUBING, SUCTIONIRRIGATION TUBE)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 8662597
• Report Number: 9610773-2019-00067
• Device Sequence Number: 16689807
• Product Code: GCJ
• UDI-Device Identifier: 04042761052641
• UDI-Public: 04042761052641
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K923982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2019

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: WA51181L
• Device Catalogue Number: WA51181L
• Device Lot Number: 172W
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS HANDLE "HIQ+" (WA51172A)