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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTECH SA ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE

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MEDTECH SA ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
Model Number ROSA ONE
Device Problem Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/14/2020
Event Type  malfunction  
Manufacturer Narrative
The device has not been evaluated yet for investigation purpose. Once the evaluation is performed, a follow-up medwatch report will be submitted. (b)(4).
 
Event Description
Company field service director received a phone call from the surgeon. She was not happy with her recent procedure which was a redo from an aborted procedure from the previous week. Of the 14 electrodes she placed, 12 were measured 4 ¿ 6 mm deep from the intended target. A company field service engineer (fse) was in the operating room to assist in this very touchy procedure to lend his expertise. Between the fse, the surgeon and the pmt electrode rep they had agreed on calculations for the electrodes ahead of time ¿ and 12/14 electrodes were off. On the phone, the surgeon told that 2 other sites have the identical issue ¿ (b)(6) hospital, that the company field service director believe are using pmt electrodes. Surgeon told that prior to the 3. 1 software configuration, she had great results and no one was reporting issues for depth and now after the software, there are issues.
 
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Brand NameROSA ONE
Type of DeviceCOMPUTER-ASSISTED SURGICAL DEVICE
Manufacturer (Section D)
MEDTECH SA
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR 34000
Manufacturer (Section G)
MEDTECH SA
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR 34000
Manufacturer Contact
jay sharma
1520 tradeport drive
jacksonville, FL 32218
9047414400
MDR Report Key9691565
MDR Text Key200847518
Report Number3009185973-2020-00036
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182417
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/11/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROSA ONE
Device Catalogue NumberROSAS00203
Device Lot Number3.1.1.1295
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/26/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

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