MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN ELECTROSURGICAL IRRIGATOR

Catalog Number	901001IRRO
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 codman electrosurgical irrigator (901001irro) blew the fuse.It is unknown under what circumstance this event occurred; however, no patient injury, death or surgical delay was reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields.The codman electrosurgical irrigator (901001irro) was returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were identified.Failure analysis: evaluation of the codman electrosurgical irrigator noted that the fuses were blown and needed to be replaced.The irrigator worked properly after replacement of the fuses; no faults were found.Safety and final tests were performed within specification.Root cause analysis: a potential cause of the reported failure may relate to an overvoltage condition occurring from input.

• Brand Name: CODMAN ELECTROSURGICAL IRRIGATOR
• 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: 19594663
• Report Number: 3013886523-2024-00188
• Device Sequence Number: 19873731
• Product Code: GEI
• UDI-Device Identifier: 10381780532873
• UDI-Public: 10381780532873
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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: Other
• Device Catalogue Number: 901001IRRO
• 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: 05/27/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• 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