MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. FORCEPS MCO781 95MM INSERTOR T TUBE; PFM11

Catalog Number MCO781

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Device history record (dhr) - the dhr was reviewed and no anomalies that could be associated with the complaint were observed.The forceps mc0781 was returned for evaluation: failure analysis - the evaluation was unable to conclusively verify the complaint as valid.The received device is complaint with the specifications.It works properly with a t tube 12mm long.Root cause - the investigation did not highlight any defect, this complaint is not related to the received device.This issue is due to the use of a t tube not compatible (6mm long).

Event Description

A facility reported that during testing, the forceps mco781 was unable to push the t tube to the ear.The t tube adapted to the mco781, entered in the ear hole, but the inserter mco781 did not release it.There was no patient involvement as this occurred during testing.

• Brand Name: FORCEPS MCO781 95MM INSERTOR T TUBE
• 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: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 11820883
• MDR Text Key: 253208398
• Report Number: 2523190-2021-00099
• 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: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCO781
• Device Lot Number: 5372252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Date Manufacturer Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2021
• 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