MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD ELECTROSURGICAL GENERATOR

Catalog Number	901001ESUO
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electrosurgical generator pool unit (901001esuo) was returned for evaluation to the service & repair center.The device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: the internal inspection did confirm the reported issue.It was noted that the electrosurgical generator pool unit was returned in very poor condition of both outside and inside.The hosing top was bent, front cover was damaged and loose - only attached with three screws, the fourth screw was loose inside; replacement of housing top and front cover was needed.The boards inside were loose, likely not assembled correctly after disassembly.The rotary encoder for coag and cut was not working properly and needed renewal.The cable ties of the balloon coil for cut connector were cut, which means the coil was loose and cannot function properly.The footswitch housing was heavily corroded, and paint layer had peeled off.The plug's strain relief was damaged, and a foot was missing, requiring replacing the entire footswitch.The repair, rf output power & safety test must be performed.Root cause analysis: based on the failure analysis, the complaint was confirmed by the repair center.The root cause for reported issue is user mishandling.
Event or Problem Description
It was reported that the electrosurgical generator pool unit (901001esuo) had "bipolar channel 2 functioning anomalies".The issue was reportedly discovered "at the beginning of the surgery", resulting in a delay of at least 30 minutes.It is unclear whether the delay occurred prior to the surgery or during active surgery.No patient adverse event was reported.

• Brand Name: ELECTROSURGICAL GENERATOR
• Common Device Name: ELECTROSURGICAL
• 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: 23378472
• Report Number: 3014334038-2025-00142
• Device Sequence Number: 8824409
• Product Code: GEI
• UDI-Device Identifier: 10886704078661
• UDI-Public: 10886704078661
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2025

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: 901001ESUO
• Device Lot Number: 2019-16-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 10/24/2025
• 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 Sex: Unknown