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 Type  Death  

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 colonoscopy procedure at an unknown date, where the colon and the transversum were treated using smart argon, the procedure was first believed to have been finished normally, when the patient's condition deteriorated and a follow-up procedure was planned.However, the patient passed away before it could be carried out.There were no reports of any device malfunctions during the initial procedure.

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for evaluation/investigation but the olympus regional repair center (rrc) hamburg, germany (received at the rrc on 2021-05-06).The evaluation at the rrc did not reveal any malfunctions of the argon plasma coagulation unit or the concomitant esg-300 hf generator but found both devices to be working correctly.Furthermore, there were no reports of any malfunction of any of the olympus medical devices used during the initial procedure.Based on the information available, there is no indication for a technical defect that might have contributed to the patient¿s death.The exact cause of the reported phenomenon and the patient¿s outcome could not be determined and is being judged as unknown.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected serial numbers of both the argon plasma coagulation unit and the concomitant hf generator without showing any abnormalities.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: 11789035
• MDR Text Key: 249417462
• Report Number: 9610773-2021-00131
• 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
• Report Date: 06/09/2021

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: 05/06/2021
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 06/07/2021
• Supplement Dates FDA Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS ELECTROSURGICAL GENERATOR "ESG-300"; OLYMPUS ELECTROSURGICAL GENERATOR "ESG-300".
• Patient Outcome(s): Death