MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF UNIT "ESG-400"; HF-GENERATORS

Model Number WB91051C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Stimulation (1412); Bradycardia (1751); Heart Failure (2206); Irregular Pulse (2469); Diminished Pulse Pressure (2606)

Event Date 11/28/2017

Event Type  Injury  

Manufacturer Narrative

The suspect medical device has not 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.Please note: this report is being submitted although the suspect medical device is not marketed in the usa.However, a similar device is marketed.Model # / catalog #: wb91051w; brand name: hf unit "esg-400"; common device name: hf- generators; 510(k): k141225; product code: gei.

Event Description

Olympus was informed that during a therapeutic cervical polypectomy procedure, the patient was twitching and her blood pressure and heart rate collapsed.After revitalization measures have been taken, the intended procedure was successfully completed with the same set of equipment.The patient reportedly recovered and there was no report of any equipment malfunction.

Manufacturer Narrative

Device evaluation: the suspect medical device was not 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, a manufacturing and quality control review was performed for the affected serial number of the esg-400 electrosurgical generator without showing any abnormalities.The case will be closed from olympus side with no further actions but the reported event/incident will be recorded for trending and surveillance purposes.

• Brand Name: HF UNIT "ESG-400"
• Type of Device: HF-GENERATORS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 7081969
• MDR Text Key: 93721043
• Report Number: 9610773-2017-00131
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: PK141225
• 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: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WB91051C
• Device Catalogue Number: WB91051C
• Other Device ID Number: 04042761081931
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HF CABLE, BIPOLAR, 4 M, FOR ESG-400 (WA00014A); VISERA ELITE VIDEO PROCESSOR OTV-S190; WORKING ELEMENT, PASSIVE (WA22367A); HF CABLE, BIPOLAR, 4 M, FOR ESG-400 (WA00014A); VISERA ELITE VIDEO PROCESSOR OTV-S190; WORKING ELEMENT, PASSIVE (WA22367A)
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 53 YR