MAUDE Adverse Event Report: CARESTREAM HEALTH INC. CARESTREAM DRX-1 SYSTEM; DRX PLUS 3543C DETECTOR

Model Number DRX PLUS 3543C DETECTOR

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2021

Event Type  Injury  

Manufacturer Narrative

Carestream health has evaluated the drx plus 3543c detector and determined there was no malfunction and is performing as designed, intended and according to specification.The incident was a result of user error when viewing the images.The images harvested from mount sinai west hospital show an image of forceps (taken with high dose), like the missing instrument (forceps), as a very high contrast ratio above 10:1.The ghost images of the forceps observed in the subsequent images of the abdomen differ by less than 1% from background.Such a low contrast clearly indicates that the instrument was not present in the images of the abdomen.Additionally, the location of the ghost in the images exactly matches the location and position as that of the instrument the image that was captured initially without the patient.Carestream health has concluded this investigation.

Event Description

On (b)(6) 2021, carestream health (csh) was informed of an incident related to the drx plus 3543c detector which occurred at (b)(6) hospital ((b)(6)).Per the report, after a surgical procedure was completed and the patient was stitched up, per hospital protocol, the customer performed a count of surgical instruments and determined the count to be off.The customer then proceeded as follows: took 1st image of one (1) forceps using a drx revolution system and the drx plus 3543c detector (sn: (b)(4)).Took 2nd and 3rd images of patient abdomen which showed a faint signal, retained from the initial forceps image, which the customer believed to be the missing instrument.As a result, the patient was re-opened in error as the forceps were not left in the patient.There was no injury or adverse effect to the patient due to this incident.However, due to the customer error in viewing the images, the patient was re-opened after being stitched up.

• Brand Name: CARESTREAM DRX-1 SYSTEM
• Type of Device: DRX PLUS 3543C DETECTOR
• Manufacturer (Section D): CARESTREAM HEALTH INC.; 150 verona street; rochester NY 14608
• MDR Report Key: 12310935
• MDR Text Key: 266153858
• Report Number: 1317307-2021-00004
• Device Sequence Number: 1
• Product Code: MQB
• UDI-Device Identifier: 60889974000238
• UDI-Public: (01)60889974000238
• Combination Product (y/n): N
• PMA/PMN Number: K150766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 08/11/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: DRX PLUS 3543C DETECTOR
• Device Catalogue Number: 1068147
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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): Other