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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 Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/22/2020
Event Type  Injury  
Manufacturer Narrative
The diagnosis of the patient may not be possible due to the inaccurate placement of the leads that was performed with rosa one device. (b)(4). The device has not been evaluated yet for investigation purpose. Once the evaluation is performed, a follow-up medwatch report will be submitted.
 
Event Description
On (b)(6) 2020, the surgeon notified the field service engineer (fse) who assisted the surgery, that during the post op scan and merge there was deviation from the planned entry by ~5mm. The surgeon said there was no impact to the patient, but the reading on the rns depth leads will be affected as they are not in the planned location. The patient was registered using contactless registration. The patient was wearing a face mask during the ct scan, so the metal bridge of the face mask as well as the elastic loops of the mask were prominent in the scan. The verification process looked to be within acceptable range and no noticeable shifts in the head occurred to the fse¿s and surgeon¿s knowledge.
 
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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 Key10348747
MDR Text Key202341488
Report Number3009185973-2020-00187
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 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2020
Is this an Adverse Event Report? Yes
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 Received06/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/07/2018
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

Patient Treatment Data
Date Received: 07/31/2020 Patient Sequence Number: 1
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