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U.S. Department of Health and Human Services

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

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OLYMPUS WINTER & IBE GMBH HF UNIT "ESG-400" HF-GENERATORS Back to Search Results
Model Number WB91051C
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/04/2019
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. 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 one day after a therapeutic transurethral resection of the prostate (turp) procedure, the patient was transferred to icu and passed away due to massive hemorrhage. The user facility reported that the hemostasis was poor intraoperatively. However, the turp was completed with the same set of equipment. An on-site investigation on (b)(6) 2019 revealed that the hf cables of the generator and spare generator (ues-40) did not function correctly related to contact quality and electricity leakage. No further information was provided.

 
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Brand NameHF UNIT "ESG-400"
Type of DeviceHF-GENERATORS
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg 22045
GM  22045
Manufacturer (Section G)
OLYMPUS WINTER & IBE GMBH
rheinstrasse 8
teltow
Manufacturer Contact
daniel wladow
kuehnstrasse 61
hamburg  22045
  22045
4940669662
MDR Report Key8844795
Report Number9610773-2019-00096
Device Sequence Number1
Product CodeGEI
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 08/16/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/31/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberWB91051C
Device Catalogue NumberWB91051C
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/14/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/20/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 07/31/2019 Patient Sequence Number: 1
Treatment
OLYMPUS SURGMASTER ELECTROSURGICAL UNIT (UES-40)
OLYMPUS UNSPECIFIED HF CABLES
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