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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 WB91051W
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Stenosis (2263)
Event Date 05/29/2018
Event Type  Injury  
Manufacturer Narrative
The suspect medical devices have 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 devices are returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
 
Event Description
Olympus was informed that during a follow-up appointment after a successfully completed therapeutic transurethral resection of the prostate (turp) procedure, it was found that the patient had developed a severe meatal stenosis.Therefore, a buccal mucosal graft (bmg) urethroplasty procedure was performed on (b)(6) 2018 to treat the injury.There were no reports of any device malfunctions during the initial turp procedure.
 
Manufacturer Narrative
The suspect medical device and the concomitant medical products were returned to the manufacturer for evaluation/investigation.The evaluation/investigation did not reveal any malfunctions of the hf-generator or the concomitant medical products but found all items to be functioning correctly.The generator¿s error log was reviewed, which contained 24 entries, which, however, are all unrelated to the reported phenomenon.The patient¿s burns can only have been caused by leakage currents that penetrated the tissue away from the intended circuit, instead flowing through some alternate path.This may happen, for example, if a non-conducting lubricant is used, or if the patient is not positioned and thus not insulated correctly during the procedure.Therefore, this event/incident was attributed to use error.Also, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot or serial numbers of all devices involved 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.Furthermore, the user will be informed about the investigation results.
 
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Brand Name
HF UNIT "ESG-400"
Type of Device
HF-GENERATORS
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg
MDR Report Key8295732
MDR Text Key134701160
Report Number9610773-2019-00047
Device Sequence Number1
Product Code GEI
UDI-Device Identifier04042761076838
UDI-Public04042761076838
Combination Product (y/n)N
PMA/PMN Number
K141225
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 03/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberWB91051W
Device Catalogue NumberWB91051W
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2019
Was the Report Sent to FDA? No
Date Manufacturer Received03/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
OLYMPUS BIOPSY FORCEPS, SPOON TYPE (A20713A); OLYMPUS FOOT SWITCH, DOUBLE (WB50402W); OLYMPUS HF CABLE, BIPOLAR (WA00014A); OLYMPUS INNER SHEATH (A22040A); OLYMPUS IRRIGATION PORT (A22053A); OLYMPUS LG CABLE, 2.8 MM (WA03300A); OLYMPUS OBTURATOR, 24 FR. (A22081A); OLYMPUS OBTURATOR, OPTICAL (A22071A); OLYMPUS OUTER SHEATH, 26 FR. (A22026A); OLYMPUS TELESCOPE "OES ELITE" (WA2T430A); OLYMPUS WORKING ELEMENT, PASSIVE (WA22367A); OLYMPUS BIOPSY FORCEPS, SPOON TYPE (A20713A); OLYMPUS FOOT SWITCH, DOUBLE (WB50402W); OLYMPUS HF CABLE, BIPOLAR (WA00014A); OLYMPUS INNER SHEATH (A22040A); OLYMPUS IRRIGATION PORT (A22053A); OLYMPUS LG CABLE, 2.8 MM (WA03300A); OLYMPUS OBTURATOR, 24 FR. (A22081A); OLYMPUS OBTURATOR, OPTICAL (A22071A); OLYMPUS OUTER SHEATH, 26 FR. (A22026A); OLYMPUS TELESCOPE "OES ELITE" (WA2T430A); OLYMPUS WORKING ELEMENT, PASSIVE (WA22367A)
Patient Outcome(s) Required Intervention;
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