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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICHARD WOLF GMBH HF BIPOLAR CONNECTING CABLE L5M

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RICHARD WOLF GMBH HF BIPOLAR CONNECTING CABLE L5M Back to Search Results
Model Number 8108.252
Device Problems Break (1069); Fire (1245); Structural Problem (2506); Power Problem (3010)
Patient Problem Burn(s) (1757)
Event Date 07/16/2018
Event Type  malfunction  
Manufacturer Narrative
Rwmic is requesting additional and missing information from rw(b)(4).The device evaluation is underway but is not yet fully completed.Rwmic will submit a follow up report as appropriate when new/additional information becomes available.
 
Event Description
Richard wolf medical instruments corporation, hereinafter referred to as rwmic was notified on 8/23/2018 by richard wolf (b)(4), hereinafter referred to as rw(b)(4) of an incident that occurred on (b)(6) 2018.The user facility reported that during the use (cutting coagulation mode) by the doctor that the resectoscope stopped working in the middle of the operation and ignited the tissues.The flames caused severe burns on the patient.First investigations showed that a breakage of the cable had occurred.The isolation of the cable was damaged at the break so that the strand was exposed.
 
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Brand Name
HF BIPOLAR CONNECTING CABLE L5M
Type of Device
HF BIPOLAR CONNECTING CABLE L5M
Manufacturer (Section D)
RICHARD WOLF GMBH
pforzheimer street 32
knittlingen, gm 75438
GM  75438
Manufacturer (Section G)
RICHARD WOLF GMBH
pforzheimer street 32
knittlingen, gm 75438
GM   75438
Manufacturer Contact
oliver ehrlich
pforzheimer street 32
knittlingen, gm 75438
GM   75438
MDR Report Key7824438
MDR Text Key118544767
Report Number9611102-2018-00013
Device Sequence Number1
Product Code FAS
UDI-Device Identifier04055207000922
UDI-Public04055207000922
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K062720
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/30/2018
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 Number8108.252
Device Catalogue Number8108.252
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/30/2018
Initial Date FDA Received08/28/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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