MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH ARGON PLASMA COAGULATION UNIT "APU-300"; ELECTROSURGICAL UNITS, MONOPOLAR, ARGON-ENHANCED COAGULATION

Model Number WA90004W

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

Patient Problem Bowel Perforation (2668)

Event Date 12/01/2020

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 during an unspecified procedure the patient sustained a minor perforation of the colon wall.No further information was provided.

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for evaluation/investigation but was examined by an olympus service technician at the customer facility without finding any malfunctions of the argon plasma coagulation unit.There were also no reports of any malfunctions of the argon plasma coagulation unit or any of the concomitant medical devices.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected serial number of the argon plasma coagulation unit without showing any abnormalities.Based on the information available, the exact cause of the reported phenomenon and the patient¿s outcome could not be determined and is being judged as unknown.However, there is no indication that a technical cause led to the reported patient injury, rather it can most likely be attributed to the patient coughing during the procedure as described in the event description.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: ARGON PLASMA COAGULATION UNIT "APU-300"
• Type of Device: ELECTROSURGICAL UNITS, MONOPOLAR, ARGON-ENHANCED COAGULATION
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10958311
• MDR Text Key: 219870101
• Report Number: 9610773-2020-00287
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761083560
• UDI-Public: 04042761083560
• Combination Product (y/n): N
• PMA/PMN Number: K180200
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: WA90004W
• Device Catalogue Number: WA90004W
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 12/22/2020; 03/23/2021
• Supplement Dates FDA Received: 12/22/2020; 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED ARGON PROBE; UNSPECIFIED ARGON PROBE
• Patient Outcome(s): Required Intervention