MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS FETAL SPIRAL ELECTRODE; FETAL SPIRAL ELECTRODE, SINGLE

Model Number 989803137631

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Follow-up report will be submitted once the investigation is complete.This is being considered a serious injury, as emergent care was needed to remove the piece of the spiral from the infant's scalp.A piece of the fetal spiral electrode (fse) (metal spiral fragment) remained in the infant's scalp following delivery and removal of the fse.We are still in the process of assessing if there's a risk to health.This complaint is being reported in order to meet the reporting deadiline.

Event Description

The customer reported that a piece of a fetal spiral electrode was found in the infant's scalp.There was patient involvement.Patient information has been requested.

Manufacturer Narrative

There has been no response for additional information.This complaint is over 90 days old.This complaint will be closed in accordance with philips¿ processes.We are considering this complaint to be a product malfunction.The customer returned unused material which was not in use at the time of the incident.This material was not evaluated.The customer had discarded the fetal spiral electrode assembly and the fragment was not made available for evaluation.Although the actual cause of the reported problem is not known, it is possible that the incident was caused by over-torquing of the fetal spiral electrode during placement or removal by the user.

Manufacturer Narrative

The device serial number is unknown.A return material authorization was provided to the customer for return of the 989803137631 fetal scalp electrode (fse) that was in use during the reported incident for evaluation.However, it was reported that the customer had discarded the fse assembly and the fragment was not available for evaluation.The customer did return unused product that was not in use at the time of the reported incident.This material was not evaluated.Since the product involved in the reported incident was not available for evaluation, we are considering this to be a malfunction of unknown cause.Although the actual cause of the reported problem is not known, it is possible that the incident was caused by over-torquing of the fse during placement or removal by the user.The ifu for the fse states in a warning not to over rotate the fse.Patient information has been requested but not provided.Patient information including date of event were requested but not provided.

Event Description

The customer reported that a piece of a fetal spiral electrode (fse) was found in the infant's scalp.This is being considered a serious injury, as emergent care was needed to remove the piece of the spiral from the infant's scalp.A piece of the fse remained in the infant's scalp following delivery.The fragment was removed from the infant¿s scalp.The infant was treated with antibiotics and recovered well.

• Brand Name: FETAL SPIRAL ELECTRODE
• Type of Device: FETAL SPIRAL ELECTRODE, SINGLE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810
• MDR Report Key: 5870010
• MDR Text Key: 51902752
• Report Number: 1218950-2016-04900
• Device Sequence Number: 1
• Product Code: HGP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K030691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 989803137631
• Device Lot Number: 160059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention