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

Model Number	INSIGHT2
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received regarding the reported injury, a follow up will be filed.
Event or Problem 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
• Common Device Name: FLOUROSCAN INSIGHT MINI C-ARM FLOUROSCOPIC IMAGING SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• MDR Report Key: 8587901
• Report Number: 1220984-2019-00045
• Device Sequence Number: 1666904
• Product Code: JAA
• UDI-Device Identifier: 15420045505896
• UDI-Public: 15420045505896
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: INSIGHT2
• Device Catalogue Number: INSIGHT2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1