MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH SINGLE USE PLASMA COAGULATION PROBE "AXIAL ARGON PA-211U", 2.3 X 2200 MM; ARGON-ENHANCED ENDOSCOPIC ELECTROSURGICAL ELECTRODE

Model Number WA94002A

Device Problem Output Problem (3005)

Patient Problem Bowel Perforation (2668)

Event Date 03/10/2023

Event Type  Injury  

Manufacturer Narrative

To date, this device has not been returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The customer reported to olympus that during an attempt to coagulate an angiodysplasia in the coecum using this single use plasma coagulation probe, the patient's muscles contracted when the foot switch was actuated.The argon probe did not ignite, and no coagulation was achieved on the site.Then a change was made to a new probe, and the same problems occurred at the same spot.It was only when a spot about 5 cm away from the original spot was accessed that ignition and coagulation occurred.In the evening, the patient was then found to have a perforation in the coecum at the first location.Additional information received that the patient had to be operated because of the perforation but is now symptom-free.The probe was checked for intactness and rinsed 2 times before the examination.No abnormalities were found.There were no reports of further patient or user harm associated with this event.Patient identifiers: (b)(6) 1st of 2 probes used.(b)(6) 2nd of 2 probes used.This report is for (b)(6).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, the subject device was not returned for an evaluation; therefore, an exact could not be determined.However, in addition to a possible device defect, the selected settings on the generator and argon plasma unit (apu), and excessive moisture around the probe tip can negatively affect the activation of the probe.Furthermore, muscle and nerve stimulation (reported by the customer), is one of the known possible side effects that can occur when using the probe in conjunction with a high frequency generator.This supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Additional information has been added to d9 and h4.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE PLASMA COAGULATION PROBE "AXIAL ARGON PA-211U", 2.3 X 2200 MM
• Type of Device: ARGON-ENHANCED ENDOSCOPIC ELECTROSURGICAL ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16802846
• MDR Text Key: 313909262
• Report Number: 9610773-2023-01130
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 14042761083420
• UDI-Public: 14042761083420
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K180200
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA94002A
• Device Catalogue Number: WA94002A
• Device Lot Number: U2112074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: APC DEVICE ECG-300 AND COLOSCOPE FROM OLYMPUS.
• Patient Outcome(s): Required Intervention; Other