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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RWGMBH; ERBE RESECTOSCOPE
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RWGMBH; ERBE RESECTOSCOPE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Type  Death  
Event Description
On august 24, 2017, an independent sales agent for rwmic, the us distribution partner for rwgmbh, was observing a surgery at the above mentioned facility when he received a complaint regarding an adverse event.Event was described as follows: on (b)(6), an unknown procedure was performed on a patient (possibly a transurethral resection of prostate (turp) or bladder tumor (turbt)) and patient started to bleed in post-op recovery room.Patient was transferred back to or in order to stop the bleeding.After bleeding was presumably stopped, patient was transferred to post-op where bleeding resumed or became more pronounced.Patient was returned to the or for the second time following the initial surgery at which time bleeding could not be stopped and the patient expired.Complainant did not allege that the rwgmbh instruments were suspected of causing or contributing to the patient's expiration.Additionally, hospital resumed use of the same devices for another surgery on (b)(6) 2017.No additional complaints or problems with any rwgmbh instruments associated with this event have been reported since that time.Attached is a list of known devices used during the (b)(6) 2017 procedure.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
RESECTOSCOPE
Type of Device
RESECTOSCOPE
Manufacturer (Section D)
RWGMBH; ERBE
MDR Report Key17527754
MDR Text Key321043140
Report NumberMW5134685
Device Sequence Number1
Product Code FJL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 09/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Patient Sequence Number1
Treatment
FDC,HIH, FAS,GEI WORKING ELEMENT, INNER SHEATH, O
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