MAUDE Adverse Event Report: ORTHOSCAN, INC. ORTHOSCAN MINI C-ARM X-RAY SYSTEM FD-OR

Model Number 1000-0004

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported a nurse was injured when manipulating an orthoscan mini c-arm.One finger was fractured when the c-arm joint was folding.The exact date of incident was not reported, however the reporter stated the injury occured two months prior to reporting to the manufacture.In the review of photos received from the reporter, it was determined the flex arm joints were missing.Further, the customer had taped handwritten signs on the unit to warn users of the hazard.The manufacture has no documentation of any customer complaints regarding the flex arm joint covers nor any preventative maintenance documentation.

• Brand Name: ORTHOSCAN MINI C-ARM X-RAY SYSTEM FD-OR
• Type of Device: MINI C-ARM X-RAY SYSTEM FD-OR
• Manufacturer (Section D): ORTHOSCAN, INC.; 14555 n. 82nd street; scottsdale, az
• Manufacturer (Section G): ORTHOSCAN; 15444 n. 82nd street; scottsdale, az
• Manufacturer Contact: steve seeman ; 15444 n. 82nd street; scottsdale, az ; 5038010
• MDR Report Key: 10271325
• MDR Text Key: 201847668
• Report Number: 3005254598-2020-00001
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K051754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1000-0004
• Device Catalogue Number: 1000-0004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2020
• Initial Date FDA Received: 07/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2016
• 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
• Patient Outcome(s): Required Intervention