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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICHARD WOLF GERMANY (RWGMBH) RIGID ENDOSCOPIC GRASPING FORCEPS

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RICHARD WOLF GERMANY (RWGMBH) RIGID ENDOSCOPIC GRASPING FORCEPS Back to Search Results
Model Number 8486.621
Device Problems Bent (1059); Material Fragmentation (1261)
Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 02/09/2018
Event Type  malfunction  
Manufacturer Narrative
Actual device returned to manufacturer and examined on 23feb2018. Visual inspection of forceps revealed they are bent distally and that the jaw part of the forceps is missing. Hardness test was performed on jaw part passed specifications. Most likely broke due excessive force being applied combined with normal wear and tear over time. Device approximately 9 years old. No similar complaints of broken jaw have been received on this device type 8486621. Richard wolf (b)(4) considers this matter closed. However, in the event (b)(4) receives any additional information a follow up report will be submitted to fda. (b)(4).
 
Event Description
Richard wolf (b)(4) was informed by the user facility that grasping forceps (id #8486. 21) broke during use and the jaw part of the device still remains in the patient's carpus. User facility emailed and called to request missing/additional information, no response as of 05mar2018. Manufactured date: 28apr2009, lot size: (b)(4) units, purchase date: 10aug2009.
 
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Brand NameRIGID ENDOSCOPIC GRASPING FORCEPS
Type of DeviceGRASPING FORCEPS
Manufacturer (Section D)
RICHARD WOLF GERMANY (RWGMBH)
32 pforzheimer street
knittlingen, 75438
GM 75438
Manufacturer (Section G)
RICHARD WOLF GERMANY (RWGMBH)
32 pforzheimer street
knittlingen, 75438
GM 75438
Manufacturer Contact
heiko seider-biedermann
32 pforzheimer street
knittlingen, 75438
GM   75438
MDR Report Key7314369
MDR Text Key101855358
Report Number9611102-2018-00001
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K963022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 02/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8486.621
Device Catalogue Number8486.621
Device Lot Number1066632
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/29/2009
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: 03/05/2018 Patient Sequence Number: 1
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