MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH SUCTION/IRRIGATION TUBE, 5 X 360 MM, BUTTON, UNIPOLAR, FOR HIQ+ HANDLE; SUCTIONIRRIGATION SYSTEM (HANDLE, VALVE TUBING, SUCTIONIRRIGATION TUBE)

Model Number WA51138A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Peritonitis (2252)

Event Date 04/29/2020

Event Type  Injury  

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 Description

Olympus was informed that after a therapeutic total laparoscopic gastrectomy procedure the patient developed peritonitis.No further information was provided, but there were no reports of any device malfunctions.

Manufacturer Narrative

Additional information: lot number.Manufacturer date.Device evaluation: the suspect medical device was returned to the manufacturer for investigation.The investigation confirmed that the coating of the suction/irrigation tube is severely damaged.This damage was caused by applying tools.The damage resulted in a short circuit between the trocar and the shaft.Therefore, this event/incident was attributed to use error.It cannot be conclusively determined whether the damage to the insulation was caused during the last operation/usage of the instrument or the instrument was used despite present damage.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 suction/irrigation tube without showing any abnormalities.The case will be closed from olympus side without 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: SUCTION/IRRIGATION TUBE, 5 X 360 MM, BUTTON, UNIPOLAR, FOR HIQ+ HANDLE
• 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: 10037763
• MDR Text Key: 192159862
• Report Number: 9610773-2020-00116
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761024341
• UDI-Public: 04042761024341
• 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: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WA51138A
• Device Catalogue Number: WA51138A
• Device Lot Number: 175W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention