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Adverse Event Report

DRAGER MEDICAL AG & CO. KGAA SOLA 700 SURGICAL LIGHT   back to search results
Model Number SOLA 700
Event Date 08/30/2001
Event Type  Malfunction   Patient Outcome  Other;
Event Description

During a surgery the central handle of the sola 700 fell down into the wound of the pt. The pt was not injured.

 
Manufacturer Narrative

Investigation has been started, but is not yet finished. Results will be reported in the follow up report.

 
Manufacturer Narrative

Drager investigated the surgical light involved in the reported complaint at the hosp site. Additional tests on the handle and on the focus unit where the handle is to be attached have been done at the manufacturer's facility. These investigation led to the result that the dimensions of the handle were slightly decrease due to a couple of sterilising procedures. Therefore the handle rested on the focus unit per friction for a while and the user did not fully fixed the handle as it is described in the user manual. The user must hear a "click" to be assure that the handle is fully fix on the focus unit. Co classified the reported complaint as a user error. Nevertheless a quality improvement action has been initialised to increase the dimensional stableness of the handle.

 
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Brand NameSOLA 700
Type of DeviceSURGICAL LIGHT
Baseline Brand NameSOLA 700
Baseline Generic NameSURGICAL LIGHT
Baseline Catalogue NumberNA
Baseline Device FamilySOLA 700
Baseline Device 510(K) NumberK010724
Baseline Device PMA Number
Baseline Shelf Life Information No
Baseline Preamendment? No
Transitional? Yes
510(K) Exempt? No
Shelf Life(Months)NA
Manufacturer (Section F)
DRAGER MEDICAL AG & CO. KGAA
moislinger allee 53-55
lubeck
GERMANY 23542
Manufacturer (Section D)
DRAGER MEDICAL AG & CO. KGAA
moislinger allee 53-55
lubeck
GERMANY 23542
Manufacturer Contact
frank clanzett
moislinger allee 53-55
lubeck  
GERMANY   23542
011 494 51-8822868
Device Event Key343836
MDR Report Key354616
Event Key334113
Report Number9611500-2001-00014
Device Sequence Number1
Product CodeFTD
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 10/04/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/04/2001
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberSOLA 700
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Agena
Event Location Not Applicable
Date Manufacturer Received09/05/2001
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/2001
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Database last updated on January 30, 2009

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