MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD ROTO-LOK ATRAU ALLIS FCPS 5MM; GRASPING FORCEPS

Model Number	625113
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
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
A facility reported that an unspecified jarit (atraumatic grasper laparoscopic surgery) was used during surgery when the tip of the instrument fell apart inside the patient.The surgeon looked for the two small pieces that came off and was able to remove them.The two pieces and the instrument were saved.A replacement device was available for use.An x-ray was not taken as staff did not feel a portable x-ray would capture the miniscule size of the pieces.The surgeon felt confident that all pieces were located.No patient harm or significant increase in surgery time occurred.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The previous reported serial number is invalid, as this is not a serialized product.The roto-lok atrau allis fcps 5mm (625113) were not returned to the manufacturer.However, visual evaluation of the photos provided by the customer was performed.Per the provided images, the jaws of the atraumatic allis grasp fcps had a broken piece detached from the device.The broken piece was visible, but not clear.The broken piece may be from the hinge.A broken hinge may result from rough handling or excessive force on the handles.The reported complaint was confirmed.No manufacturing, workmanship or material deficiency has been identified.

• Brand Name: ROTO-LOK ATRAU ALLIS FCPS 5MM
• Common Device Name: GRASPING FORCEPS
• 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: 16640580
• Report Number: 3014334038-2023-00037
• Device Sequence Number: 5458546
• Product Code: GCJ
• UDI-Device Identifier: 10381780147121
• UDI-Public: 10381780147121
• Combination Product (Y/N): N
• PMA/510(K) Number: K931928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023
• 2 Devices were Involved in the Event: 1 2

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 Model Number: 625113
• Device Catalogue Number: 625113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 05/10/2023
• 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