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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRACCO INJENEERING SA ARTICULATING ARM OF EMPOWERCTA+

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BRACCO INJENEERING SA ARTICULATING ARM OF EMPOWERCTA+ Back to Search Results
Model Number 017416
Device Problems Break (1069); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Physical Property Issue (3008)
Patient Problem No Patient Involvement (2645)
Event Date 01/26/2018
Event Type  malfunction  
Manufacturer Narrative
Empowercta+ articulating and j-arm broke away and fell. The operator hold the system when it fell. There was no patient nor operator injury. However there may be the potential of injury, if the issue was to reoccur. The investigation is ongoing. (b)(4).
 
Event Description
On (b)(6) 2018, a healthcare professional reported to bracco injeneering a device malfunction with the use of the articulating arm of empowercta+. The report was forwarded to bracco drug safety on 23-feb-2018. On (b)(6) 2018, the empowercta+ articulating and j-arm broke away and fell. The operator held the system when it fell. There was no patient nor operator injury. However there may be the potential of injury, if the issue was to reoccur. A quality investigation is ongoing.
 
Manufacturer Narrative
Empowercta+ articulating and j-arm broke away and fell. The operator hold the system when it fell. There was no patient nor operator injury. However there may be the potential of injury, if the issue was to reoccur. The investigation shows that the general aspect of the arm tends to indicate that the j-arm has been used before, that the subassembly j-arm / tube has been damaged by hospital before the full breakage but no part has been replaced. The design of the j-arm as well as the manufacturing cannot be considered as the root cause of this failure. The probable root cause of the failure is the ceiling mount being used after the expected life of the device. The case is then considered closed.
 
Event Description
On (b)(6) 2018, a healthcare professional reported to (b)(4) injeneering a device malfunction with the use of the articulating arm of empowercta+. The report was forwarded to (b)(4) drug safety on 23-feb-2018. On (b)(6) 2018, the empowercta+ articulating and j-arm broke away and fell. The operator held the system when it fell. There was no patient nor operator injury. However there may be the potential of injury, if the issue was to reoccur. The investigation shows that the general aspect of the arm tends to indicate that the j-arm has been used before, that the sub-assembly j-arm / tube has been damaged by hospital before the full breakage but no part has been replaced. The design of the j-arm as well as the manufacturing cannot be considered as the root cause of this failure. The probable root cause of the failure is the ceiling mount being used after the expected life of the device. The case is then considered closed. Most recent follow-up information incorporated above includes: on 25-apr-2018: quality investigation report added to the case. 12-jun-2018: case corrected after internal review by (b)(4). (b)(4) removed as importer. Importer number removed from report number page. The investigation report attachment was removed from file attachments page. Corresponding worldwide case id provided. A new form fda 3500a case was generated. (b)(4).
 
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Brand NameARTICULATING ARM OF EMPOWERCTA+
Type of DeviceARTICULATING ARM OF EMPOWERCTA+
Manufacturer (Section D)
BRACCO INJENEERING SA
46 avenue sévélin
lausanne, CH-10 04
SZ CH-1004
MDR Report Key7303600
MDR Text Key101304511
Report Number3004753774-2018-00001
Device Sequence Number1
Product Code IZQ
Combination Product (y/n)N
PMA/PMN Number
K071378
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Replace
Type of Report Initial,Followup,Followup
Report Date 04/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number017416
Device Catalogue Number017416
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/15/2018
Event Location Hospital
Date Report to Manufacturer04/25/2018
Date Manufacturer Received04/25/2018
Is This a Reprocessed and Reused Single-Use Device? No

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