MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD R-PEAN FCPS 6-1/4 CVD SATIN; N/A

Catalog Number	106171
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the r-pean forceps 6-1/4 cvd satin (106171) failed to effectively clamp down (or ratchet) and came off the umbilical cord of a newborn baby during delivery.It was subsequently reported that the clamp came off the umbilical cord closest to baby after it was cut, immediately after birth, during a caesarean section.There was some blood loss noted when the infant was immediately moved to the panda warmer.A plastic clamp was placed on the umbilical cord of the newborn.The operating room staff all verified the clamp was applied to the infant prior to cutting the cord; but it fell off immediately prior to the infant being moved to the panda warmer for resuscitation.The count of the clamps on the field of the caesarean-section were correct and all were accounted for.Staff investigated by checking the four kelly clamps in the instrument casket and the kelly in question was found to click but not connect correctly and it did not close correctly or tightly.The infant was transferred to hershey medical center to a higher level of care and discharged two days later to home with parents.
Additional Manufacturer Narrative
The rochester-pean forceps 6-1/4 curved satin (106171) was returned for evaluation.The device history record (dhr) was reviewed and no abnormalities related to the reported issue were identified.Failure analysis: visual/functional evaluation was performed.It was noted that the r-pean forceps were received in used condition with scratches and wear on the surface.The jaws were able to meet properly.The second and third locking ratchets met tightly and securely.The first ratchet held tightly; however, appeared to be partially out of alignment.Additional review by the product inspection site could not duplicate the reported issue of not locking/meeting properly.Root cause analysis: the reported complaint was confirmed.The returned r-pean forceps with the first ratchet appearing to be misaligned due to wear.The issue of coming apart may be the result of misalignment due to wear.Sales records indicate this lot was last sold in august 2022.Per the instructions for use (ifu), "the instrument must be inspected to assure proper functioning prior to each use with particular attention paid to the condition of all moving parts, tips, box locks, ratchets and cutting edges." no manufacturing, workmanship or material deficiency has been identified.
Event or Problem Description
N/a.

• Brand Name: R-PEAN FCPS 6-1/4 CVD SATIN
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19905828
• Report Number: 3014334038-2024-00158
• Device Sequence Number: 8673996
• Product Code: HRQ
• UDI-Device Identifier: 10381780371984
• UDI-Public: 10381780371984
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 106171
• Device Lot Number: AS2203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown