MAUDE Adverse Event Report: HOLOGIC, INC FLOUROSCAN; FLOUROSCAN INSIGHT MINI C-ARM FLOUROSCOPIC IMAGING SYSTEM

Model Number INSIGHT2

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Information (3190)

Event Date 04/05/2019

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding the reported injury, a follow up will be filed.

Event Description

It was reported by a distributor, who received a phone call directly from the customer, that due to an "unruly flex arm" a member of the staff was injured.The severity of the injury or medical intervention was not reported.A field engineer had previously been dispatched to the site and determined that the flex arm needed to be replaced.The insight system has been replaced.Attempts to obtain additional information regarding the reported injury on (b)(6) 2019 have been unsuccessful.

• Brand Name: FLOUROSCAN
• Type of Device: FLOUROSCAN INSIGHT MINI C-ARM FLOUROSCOPIC IMAGING SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer Contact: kristin fornieri ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2037318491
• MDR Report Key: 8587901
• MDR Text Key: 145541379
• Report Number: 1220984-2019-00045
• Device Sequence Number: 1
• Product Code: JAA
• UDI-Device Identifier: 15420045505896
• UDI-Public: 15420045505896
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INSIGHT2
• Device Catalogue Number: INSIGHT2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2019
• Initial Date FDA Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1