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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 MAYFIELD HEAD HOLDER ADAPTOR
Device Problem Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/23/2020
Event Type  Injury  
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.Unique identifier (udi) #: unknown.
 
Event Description
During an seeg procedure the mayfield head holder adaptor slowly loosened and then eventually slipped from it's position.This movement caused a significant head shift and caused the surgery to be delayed by 40+ minutes.This delay was because the patient had to be repositioned and re-registered for surgery.At the time of the shift, 5 electrodes had been placed and a total of 8 were going to be placed for the surgery.Two of the electrodes were removed after the shift (due to the mayfield adaptor slowly shifting which was not realized until the accuracy of the entry sites of each trajectory was checked).After the second registration, the procedure continued as planned and all trajectories were finished to completion, including the two electrodes that had previously removed.
 
Event Description
During an seeg procedure the mayfield head holder adaptor slowly loosened and then eventually slipped from it's position.This movement caused a significant head shift and caused the surgery to be delayed by 40+ minutes.This delay was because the patient had to be repositioned and re-registered for surgery.At the time of the shift, 5 electrodes had been placed and a total of 8 were going to be placed for the surgery.Two of the electrodes were removed after the shift (due to the mayfield adaptor slowly shifting which was not realized until the accuracy of the entry sites of each trajectory was checked).After the second registration, the procedure continued as planned and all trajectories were finished to completion, including the two electrodes that had previously removed.
 
Manufacturer Narrative
It was reported that during a surgery the mayfield head holder adaptor s/n mt-02-268 s18030 slowly loosened and then eventually slipped from its position.Reportedly, the company representative immediately checked the tightness and how secure the mayfield head holder adaptor was when the shift was noticed.According to him the mayfield head holder adaptor could not have been made tighter and it seemed that it had not been loosened.It was confirmed that the mayfield head holder adaptor s/n (b)(6) will not be returned at the manufacturing site for evaluation.Indeed, the company representative confirmed that the inspection he made on this part did not indicate any issue.Plus, the hospital is still using it and did not report any issue with it.Based on these elements, there is no failure detected for the mayfield head holder adaptor s/n (b)(6), and the root cause of the reported event remains unknown.Corrected data: - b4 date of this report; - d4 additional device information; - g4 date received by manufacturer; - h2 if follow-up, what type; - h3 device evaluated by manufacturer; - h4 device manufacturer date; - h6 event problem and evaluation codes; - h10 additional narratives/data.D4 unique identifier (udi) #: (b)(4).
 
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Brand Name
ROSA ONE
Type of Device
COMPUTER-ASSISTED SURGICAL DEVICE
Manufacturer (Section D)
MEDTECH SA
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR  34000
MDR Report Key10367027
MDR Text Key202358568
Report Number3009185973-2020-00189
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
PMA/PMN Number
K182417
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMAYFIELD HEAD HOLDER ADAPTOR
Device Catalogue NumberROSAS00325
Device Lot NumberROSA3-177E
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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