MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMA-OVALBUTTON"

Model Number WA22566S

Device Problem Fumes or Vapors (2529)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.The cause of the reported event cannot be determined.As part of our investigation, a sales representative will be going to the customer¿s site the next time cases are scheduled to ensure they are provided with all the possible information and training again.

Event Description

The service center was informed that during a trans urethral vaporization of prostate (turp) procedure, the anesthetist was overcome by fumes during plasma button use and complained of pleuritic pain for three days following the incident.It was reported that the odor in the operating theatre was much stronger than normal for plasma button use.The odor occurred with two of facility¿s new surgeons.The intended procedure was completed with same device.The anesthetist did not seek medical treatment and recovered at home.

Manufacturer Narrative

This supplemental report is being submitted to report the original equipment manufacturer (oem) device evaluation results.The oem reported that its impossible to perform a dhr review with unknown serial/ lot number.Instead the manufacturing and quality control review was performed for the last 24 months of production without showing any non-conformities or deviations regarding the described issue.

• Brand Name: HF-RESECTION ELECTRODE "PLASMA-OVALBUTTON"
• Type of Device: HF-RESECTION ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 9676408
• MDR Text Key: 177977275
• Report Number: 9610773-2020-00065
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761083765
• UDI-Public: 14042761083765
• Combination Product (y/n): N
• PMA/PMN Number: K152092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22566S
• Device Catalogue Number: WA22566S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/06/2020
• Supplement Dates Manufacturer Received: 02/07/2020
• Supplement Dates FDA Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ESG-400; ESG-400
• Patient Outcome(s): Other