MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD SUCTION COAG W/SPAT-TIP INS; ELECTROSURGICAL COAGULATION

Model Number	600300
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
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 the suction coag w/spat-tip ins (600300) was sparking at end of insulation and failing insulation inspections.It was reported that the instrument was not used during a procedure; thus, no patient injury, death or surgical delay occurred.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed, and no anomalies related to the reported issue were identified.The suspected suction coag w/spat-tip ins (600300) was not returned for evaluation; however, the customer provided a video of the reported failure.Visual evaluation of the provided video shows an insulated instrument that may be a suction coagulator (600300) failing insulation testing.The reported complaint was confirmed.The insulation failure may be the result of shipping damage, environmental damage or wear.No manufacturing, workmanship or material deficiency has been identified.

• Brand Name: SUCTION COAG W/SPAT-TIP INS
• Common Device Name: ELECTROSURGICAL COAGULATION
• 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: 16274793
• Report Number: 3014334038-2023-00010
• Device Sequence Number: 5949810
• Product Code: KNF
• UDI-Device Identifier: 10381780129394
• UDI-Public: 10381780129394
• Combination Product (Y/N): N
• PMA/510(K) Number: K932456
• 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): 03/20/2023

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: Other
• Device Model Number: 600300
• Device Catalogue Number: 600300
• Device Lot Number: 100161-1703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 03/20/2023
• Date Device Manufactured: 03/31/2017
• 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