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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GEOMED MEDIZIN-TECHNIK GMBH & CO. KG CARB-BITE DEBAKEY NEEDLEHOLDER; NEEDLE HOLDER

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GEOMED MEDIZIN-TECHNIK GMBH & CO. KG CARB-BITE DEBAKEY NEEDLEHOLDER; NEEDLE HOLDER Back to Search Results
Model Number 121186
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2022
Event Type  malfunction  
Event Description
It was reported that during a heart operation, the surgeon noticed that a piece of the needle holder was missing.Before the end of the operation, an x-ray was taken.The missing piece was not found in the patient's body.Medical staff did not know at which stage the device broke, but suspected it was at the beginning of the operation.The event did not lead to patient injury, but a two-hour increase in surgery time was reported.
 
Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
 
Manufacturer Narrative
The following form fields have been updated: d4, d9, h2, h3, h6, h10.The device was returned to the manufacturer.Inspection of the returned device revealed that it was manufactured by another company.The manufacturer of the device is unknown.The relabeler has been informed accordingly.The investigation has been closed.
 
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Brand Name
CARB-BITE DEBAKEY NEEDLEHOLDER
Type of Device
NEEDLE HOLDER
Manufacturer (Section D)
GEOMED MEDIZIN-TECHNIK GMBH & CO. KG
ludwigstaler strasse 27
tuttlingen, 78532
GM  78532
Manufacturer (Section G)
GEOMED MEDIZIN-TECHNIK GMBH & CO. KG
ludwigstaler strasse 27
tuttlingen, 78532
GM   78532
Manufacturer Contact
hanno haug
ludwigstaler strasse 27
tuttlingen, bw 78532
GM   78532
MDR Report Key16110119
MDR Text Key307814491
Report Number8010168-2023-00001
Device Sequence Number1
Product Code DWS
UDI-Device Identifier10381780165071
UDI-Public10381780165071
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/07/2023
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 Number121186
Device Catalogue Number121186 / AR 278-20-61
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 12/09/2022
Initial Date FDA Received01/05/2023
Supplement Dates Manufacturer Received01/10/2023
Supplement Dates FDA Received02/07/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age77 YR
Patient SexMale
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