MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP E.CAM; GAMMA CAMERA

Model Number 4380221

Device Problems Mechanical Problem (1384); Use of Device Problem (1670)

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

Event Date 02/19/2015

Event Type  Injury  

Event Description

Customer narrative: "customer was installing medium energy collimator on head one, head 2 aligned, head on cart not aligned, customer pushed collimator on halfway, realized collimator not on track, attempted to pull collimator back off, collimator fell on right hand." mfr narrative: the operator of the e.Cam gamma camera nuclear medicine system was in the process of changing the collimators (accessory) prior to use of the e.Cam system.There was a misalignment, which did not allow the proper change of the collimator; however, the customer continued to perform the collimator change resulting in the collimator falling and impacting the right hand of the operator.A misaligned collimator exchange should not be attempted.Following the labeling instructions for collimator change would reduce the potential for injury or damage to the system.In this case, the customer chose to attempt to change the collimator despite the misalignment issue, which resulted in the fall of the collimator and injury.The operator injury consisted of a broken finger and cut that required an undisclosed number of stitches.There was no pt involved in the event and the incident only involved the operator of the device.

Manufacturer Narrative

(b)(6).During a review of files we determined that the patient identifier submitted with the original form fda 3500a was incorrect.This supplement corrects the patient identifier (icd).

Manufacturer Narrative

This supplement is being submitted to correct "date of event".During follow-ups on this complaint, we became aware on 06/22/2015 that the reported date of event (02/18/2015) was incorrect.The correct date of event ((b)(6) 2015) is being submitted via this supplement report.

• Brand Name: E.CAM
• Type of Device: GAMMA CAMERA
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP; 2501 north barrington rd.; hoffman estates IL 60192
• Manufacturer Contact: laura meyer ; 8473046022
• MDR Report Key: 4586387
• MDR Text Key: 5448941
• Report Number: 1423253-2015-00002
• Device Sequence Number: 1
• Product Code: IYX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: E142006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2015

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: 4380221
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2015
• Initial Date FDA Received: 03/06/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/20/2015; 06/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/1997
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention