MAUDE Adverse Event Report: GENERAL MEDICAL MERATE S.P.A. PRECISION RXI; PRECISION RXI ANALOG X-RAY SYSTEM

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Injury (2348); Suture Abrasion (2497)

Event Date 01/18/2018

Event Type  Injury  

Manufacturer Narrative

Investigation of the event is being completed by the manufacturer of the precision xr/i system which is general medical merate (gmm).Upon completion of the manufacturers investigation, (b)(6) healthcare will provide a follow up report.

Event Description

On (b)(6) 2018, the technologist at hospital (b)(6) reported that as they were positioning the table longitudinally during a gastrointestinal exam on their precision xri system, the patients left hand third digit became entrapped under the table top.As a result of the finger entrapment, the patient received a cut to their left hand third digit that required five stitches.This complaint was received on a precision rx/i system which is imported/distributed, but is not manufactured by (b)(4).The manufacturer of the precision xr/i is general medical merate (gmm).

Manufacturer Narrative

The investigation by the manufacturer general medical merate has been completed and the root cause was determined to be use error.The ge field engineer arrived at the site to evaluate the device and determined there was no malfunction with the device.The precision rxi is provided with a pair of hand grips that must be used for positioning the patient's hands keeping them in the correct and safe position.The operator's manual contains several cautions and warnings to keep patients hands away from the table top edges.The operator's manual also states if the hand grips cannot be used during the patient exam, be sure the patient does not hold onto the edge of the tabletop.For this case, the operator did not use the table hand grips or confirm the patient's hands were clear before moving the table.There have been no prior problems reported and therefore no information of similar events in the past.As a correction, the customer has been reminded to use the table hand grips and to also check to confirm the patient's hands are not near the tabletop edges during table movement.

• Brand Name: PRECISION RXI
• Type of Device: PRECISION RXI ANALOG X-RAY SYSTEM
• Manufacturer (Section D): GENERAL MEDICAL MERATE S.P.A.; via partigiani 25; seriate, 24068 ; IT 24068
• Manufacturer (Section G): GENERAL MEDICAL MERATE S.P.A.; via partigiani 25; seriate, 24068 ; IT 24068
• Manufacturer Contact: anne krueger ; 3000 north grandview boulevard; waukesha, WI 53188-1696 ; 2625443818
• MDR Report Key: 7241606
• MDR Text Key: 99029524
• Report Number: 2126677-2018-00004
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K041605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 03/05/2018

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 02/05/2018
• Supplement Dates Manufacturer Received: 03/05/2018
• Supplement Dates FDA Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/27/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 80