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

Model Number	WA90004W
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Olympus was informed that during an unspecified procedure the patient sustained a minor perforation of the colon wall.No further information was provided.
Additional 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"
• Common Device Name: ELECTROSURGICAL UNITS, MONOPOLAR, ARGON-ENHANCED COAGULATION
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10958311
• Report Number: 9610773-2020-00287
• Device Sequence Number: 19675347
• Product Code: GEI
• UDI-Device Identifier: 04042761083560
• UDI-Public: 04042761083560
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K180200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 12/22/2020; 03/23/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 12/22/2020; 03/24/2021
• 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: UNSPECIFIED ARGON PROBE; UNSPECIFIED ARGON PROBE
• Outcome Attributed to Adverse Event: Required Intervention