MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS SENOGRAPHE 800T; ANALOGIC MAMMOGRAPHIC X RAY

Device Problems Component Falling (1105); Improper or Incorrect Procedure or Method (2017); Maintenance Does Not Comply To Manufacturers Recommendations (2974); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946)

Event Date 08/25/2017

Event Type  Injury  

Manufacturer Narrative

Ge healthcare¿s investigation is ongoing.A follow up report will be submitted once the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

During a maintenance activity on a mammography system, ge healthcare field service engineer injured his finger while trying to replace the belt of the counterweight.This part has fallen on his right index finger resulting in a laceration and a fracture of bones.He was immediately treated to the emergency department of the neighboring hospital and received eight stitches.Employee returned to work without sick leave.

Manufacturer Narrative

Manufacturer contact information has been updated.Additional information regarding investigation results was received.Ge healthcare field service engineer has been reminded on (b)(6) 2017 about the need to follow adequate safety precautions and procedures during part replacement and on the need to wear adequate safety protections during intervention.

Manufacturer Narrative

Ge healthcare investigation about this event has been completed.It was reported that during a system maintenance performed on (b)(6) 2017, ge healthcare field service engineer injured his right index finger while trying to replace the belt of the counterweight.The counterweight dropped and pinched fe's right index finger which resulted in height needle sutures and crack at the tip of the right index finger bone.Field service engineer was immediately treated to the emergency department of the neighboring hospital and returned to work without sick leave.Ge healthcare investigation confirmed that the root cause of reported incident is that field service engineer did not properly follow service manual and job cards as he missed a locking rod to prevent the falling of the counterweights during part replacement which led to the reported part fall.Also, ge healthcare field service engineer confirmed that personal protective equipment (ppe) was available but he did not wear them during this intervention.Adequate safety instructions and warnings are provided in service manual regarding proper removal and replacement of gantry counterweight.Moreover, for this part replacement, job card has steps and specific tools to work safely.The system has been corrected by another field service engineer and is working per specification.No system malfunction has been identified, system worked as intended and per specifications.A reminder to the ge field service engineer on the safety steps to follow during part replacement and on the need to wear adequate protections is necessary.A supplemental report will be submitted when this reminder will be done.

• Brand Name: SENOGRAPHE 800T
• Type of Device: ANALOGIC MAMMOGRAPHIC X RAY
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc ; FR
• Manufacturer Contact: angele taormina ; 283 rue de la miniere; buc ; FR
• MDR Report Key: 6868192
• MDR Text Key: 86284338
• Report Number: 9611343-2017-00010
• Device Sequence Number: 1
• Product Code: IZH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K953250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• 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
• Patient Age: 30 YR
• Patient Weight: 55