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

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2019

Event Type  malfunction  

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 Description

Olympus was informed that during reprocessing after an unspecified laparoscopic procedure, it was noticed that a black part on the valve tube¿s water supply side was missing.It is unknown whether a fragment of the missing part may have gotten into the patient¿s body during the procedure and if yes, whether it remained inside the patient.No further information was provided.The intended procedure was completed successfully with the same set of equipment and there was no report about an adverse event or patient injury.

Manufacturer Narrative

Device evaluation: the suspect medical device was not returned to the manufacturer for evaluation/investigation but to olympus medical systems corporation (omsc), japan (returned to omsc on 2019-08-28).The evaluation/investigation confirmed that the irrigation connector of the valve tubing was damaged and that a fragment had broken off.The cause of this damage is age-related wear and tear in combination with mechanical overload by the application of excessive force.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 but, independently from the above mentioned issue, a material change of the irrigation connector was implemented to improve durability in april 2018.However, the reported event/incident will be recorded for trending and surveillance purposes and 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.
• Type of Device: SUCTIONIRRIGATION SYSTEM (HANDLE, VALVE TUBING, SUCTIONIRRIGATION TUBE)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 8934927
• MDR Text Key: 198132174
• Report Number: 9610773-2019-00114
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761052641
• UDI-Public: 04042761052641
• Combination Product (y/n): N
• PMA/PMN Number: K923982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA51181L
• Device Catalogue Number: WA51181L
• Device Lot Number: 17YW
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1