Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTECH SA ROSA ONE; COMPUTER-ASSISTED SURGICAL DEVICE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTECH SA ROSA ONE; COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
Model Number SEEG DRILL ADAPTOR 2.45MM
Device Problem Fitting Problem (2183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/22/2020
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.Unique identifier (udi) #: unknown.
 
Event Description
Company clinical representative (cr) received a phone call from the rosa advance user at (b)(6) hospital.She stated that the following complaint events happened during a seeg surgery: the surgeon says that he was having trouble with two new 2.45 mm drill adaptors.The pmt anchor bolt for the seeg electrodes and the standard 2.4 mm drill bit they normally use goes through these adaptors fine.However, the pmt anchor bolt driver could not fit through the adaptors.According to the advance user, the surgeon was only able to have the distal tip of the anchor bolt driver partially enter the adaptor but not completely go through it.Afterwards, the hospital staff members went and got the rosa tray with their old 2.45 mm drill adaptors to use and it worked fine.The delay for this complaint event was approximately 10 minutes.
 
Manufacturer Narrative
Corrected data: - b4 date of this report - d10 device availability - g4 date received by manufacturer - h2 if follow-up, what type - h10 additional narratives/data.
 
Event Description
Company clinical representative (cr) received a phone call from the rosa advance user at (b)(6) hospital.She stated that the following complaint events happened during a seeg surgery: the surgeon says that he was having trouble with two new 2.45 mm drill adaptors.The pmt anchor bolt for the seeg electrodes and the standard 2.4 mm drill bit they normally use goes through these adaptors fine.However, the pmt anchor bolt driver could not fit through the adaptors.According to the advance user, the surgeon was only able to have the distal tip of the anchor bolt driver partially enter the adaptor but not completely go through it.Afterwards, the hospital staff members went and got the rosa tray with their old 2.45 mm drill adaptors to use and it worked fine.The delay for this complaint event was approximately 10 minutes.
 
Manufacturer Narrative
It was reported that the pmt anchor bolt driver could not fit through the drill adaptors, the user was only able to have the distal tip of the anchor bolt driver partially enter but not completely go through it.The subject drill adaptors, sn (b)(6) and s/n (b)(6) , were returned at the manufacturing site for investigation.A visual inspection did not indicate any external visible damage that could have caused or contributed to the event.No further analysis was performed on the returned part as the reported event is assessed to be linked to an existing capa.The investigation performed through this capa concluded that the drill adaptor design must be improved.D4 unique identifier (udi) #: (b)(4).
 
Event Description
Company clinical representative (cr) received a phone call from the (b)(4) user at (b)(6) hospital.She stated that the following complaint events happened during a seeg surgery: the surgeon says that he was having trouble with two new 2.45 mm drill adaptors.The pmt anchor bolt for the seeg electrodes and the standard 2.4 mm drill bit they normally use goes through these adaptors fine.However, the pmt anchor bolt driver could not fit through the adaptors.According to the advance user, the surgeon was only able to have the distal tip of the anchor bolt driver partially enter the adaptor but not completely go through it.Afterwards, the hospital staff members went and got the rosa tray with their old 2.45 mm drill adaptors to use and it worked fine.The delay for this complaint event was approximately 10 minutes.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10613108
MDR Text Key209398341
Report Number3009185973-2020-00228
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
PMA/PMN Number
K200511
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 01/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSEEG DRILL ADAPTOR 2.45MM
Device Catalogue NumberROSAS00082
Device Lot NumberMPL174045-00
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2020
Was the Report Sent to FDA? No
Date Manufacturer Received01/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
-
-