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 Codes	Death (1802); Peritonitis (2252); Bowel Perforation (2668)
Date of Event	12/10/2019
Type of Reportable Event	Death
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 after a procedure to stop the bleeding of a vascular lesion in the duodenum, the patient was first released from hospital but then readmitted 24-36 hours later due to a peritonitis.The patient was admitted to icu and a laparotomy was performed which found a duodenal perforation.The patient also encountered further complications on icu, one being an infection in the arm.The patient died 4-6 days after being readmitted.There were no reports of any device malfunctions during the initial procedure.
Additional Manufacturer Narrative
The suspect medical device and the concomitant medical products were returned to the manufacturer for evaluation/investigation.The evaluation/investigation did not reveal any malfunctions of the argon plasma coagulation unit or the concomitant medical products but found all items to be functioning correctly.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 and the concomitant medical products 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, in general, the occurrence of bleeding/perforation during or after electrosurgical procedures is an expected and foreseeable side effect, clearly identified in labeling and risk assessment with justification of benefit.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: 9681367
• Report Number: 9610773-2020-00066
• Device Sequence Number: 3414094
• Product Code: GEI
• UDI-Device Identifier: 04042761083560
• UDI-Public: 04042761083560
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K180200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 04/21/2020
• 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 GENERATOR ESG-300 (WA90003W); OLYMPUS PLASMA COAGULATION PROBE (WA94002A); OLYMPUS GENERATOR ESG-300 (WA90003W); OLYMPUS PLASMA COAGULATION PROBE (WA94002A)
• Outcome Attributed to Adverse Event: Death