MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD ELECTROSURGICAL GENERATOR

Model Number	901001ESUO
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2021
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 the electrosurgical generator "charred" the tissue instead of gently coagulating it.The procedure was completed with a replacement product available, no consequences for the patient.
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 the electrosurgical generator "charred" the tissue instead of gently coagulating it.The procedure was completed with a replacement product available, no consequences for the patient.
Additional Manufacturer Narrative
Additional information received: the dysfunction was observed during procedure while the patient was under anesthesia.The procedure was completed with a replacement product available with no patient consequences.The patient is a male, around 60-years-old.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.Complaint sample was returned for evaluation: dhr - conformed to the specifications when released to stock.Failure analysis - visual inspection showed no signs of physical damage.A functional test was done, and no charring was observed during the test.The device met the specifications.The failure ¿the generator chars the tissue instead of gently coagulating it¿ reported by the customer is not confirmed.Root cause - the device was returned and investigated, visual and functional tests were performed and the device met the specifications.Nevertheless, the possible root cause for ¿the generator chars the tissue instead of gently coagulating it¿ could be due to incorrect power output (power output and display do not match).However, the complaint reported by the customer is not confirmed, so the issue is probably due to a misuse, human error.
Event or Problem Description
N/a.

• Brand Name: ELECTROSURGICAL GENERATOR
• Common Device Name: ELECTROSURGICAL
• 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: 13342823
• Report Number: 3013886523-2022-00013
• Device Sequence Number: 17123236
• Product Code: GEI
• UDI-Device Identifier: 10381780532880
• UDI-Public: 10381780532880
• Combination Product (Y/N): N
• PMA/510(K) Number: K183526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2022

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 Model Number: 901001ESUO
• Device Catalogue Number: 901001ESUO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2021
• Supplement Date Received by Manufacturer: 01/21/2022; 11/04/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 02/09/2022; 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2019
• 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 Age: 60 YR
• Patient Sex: Male