MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD OCHSNER FCPS 8 STR SATIN; N/A

Catalog Number	106220
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ratchet system/ochsner forceps 8 str satin (106220) does not stay locked; it pops open by the slightest touch or movement.During obstetrician gynecological childbirth, the instrument was used to clamp the cord on the baby.It unclamped with hardly touching the instrument or setting it down.It was reported that there was no patient injury.No surgical delay was reported.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The ochsner fcps 8 str satin (106220) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information was provided; device history record (dhr) was reviewed, and no abnormalities related to the reported issue were identified.A definitive root cause of the reported issue could not be determined.However, a probable root cause of the device not staying locked may be the result of misaligned ratchets due to wear or environmental damage.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: OCHSNER FCPS 8 STR SATIN
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17804217
• Report Number: 3014334038-2023-00157
• Device Sequence Number: 7379564
• Product Code: HRQ
• UDI-Device Identifier: 10381780023845
• UDI-Public: 10381780023845
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 106220
• Device Lot Number: AF2111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 10/19/2023
• Date Device Manufactured: 11/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown