MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. FORCEPS 3711063 GIRAFFE 90DEG VERT; PFM11

Model Number 3711063

Device Problem Device Reprocessing Problem (1091)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

This is 1 of 2 reports linked to mfg report number 3003249645-2022-00017: it has been reported that the forceps 3711063 giraffe was not suitable to ensure complete sterilization.The facility has not reported if there was patient involvement, injury or surgical delay related to this event.

Event Description

N/a.

Manufacturer Narrative

The giraffe forceps (3711063) was returned for evaluation.Device history record (dhr): the dhr was reviewed, and no anomalies related to the reported failure were observed failure analysis: evaluation of the giraffe forceps identified that the finishing of the welding was not good; there was roughness.The strength of the welding was compliant; there was no risk of breakage.Root cause: it was determined that the issue was due to an improper finishing of the welding during the manufacturing operations.An awareness has been performed to the operators.No risk for the patient, the defect is visual and was discovered before the use of the device.

• Brand Name: FORCEPS 3711063 GIRAFFE 90DEG VERT
• 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: 14240318
• MDR Text Key: 299367534
• Report Number: 3003249645-2022-00016
• Device Sequence Number: 1
• Product Code: KAE
• UDI-Device Identifier: 10381780076100
• UDI-Public: 10381780076100
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3711063
• Device Catalogue Number: 3711063
• Device Lot Number: 5856141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2021
• 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