MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. FORCEPS MCO13A ALLIG 4X1.0MM HARTMAN; PFM11

Catalog Number MCO13A

Device Problems Material Too Rigid or Stiff (1544); Use of Device Problem (1670); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident has been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

Patient 4: it was reported that during an ear procedure in the doctor's office, the device was hard to use, the resistance of the clamp resulted in an increase of the manual pressure of the operator therefore there was a movement each time unpredictable and aggressive to the surrounding anatomical environment, which result in superficial injury of the external auditory canals and eardrums without perforation, causing pain.The patient was treated with antibiotics ear drops, steroids and pain medication.Patient is expected to be recovered.

Manufacturer Narrative

Integra has completed their internal investigation on june 7, 2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: evaluation of returned device: the handles are harder to work than it usually is.However, they are still compliant with the manufacturing specifications and work properly after lubrication.Dhr review: no nonconformity for this lot.Complaints history: no complaint for this lot.Conclusion: the most probable cause of this stiffness is the lack of regular lubrication during the reprocessing of the forceps.

• Brand Name: FORCEPS MCO13A ALLIG 4X1.0MM HARTMAN
• Type of Device: PFM11
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer (Section G): INTEGRA MICROFRANCE S.A.S.; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer Contact: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5696089
• MDR Text Key: 46468147
• Report Number: 2523190-2016-00084
• Device Sequence Number: 1
• Product Code: KAE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MCO13A
• Device Lot Number: 09/02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other