MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD ELECTROSURGICAL IRRIGATOR

Catalog Number	90100IRRO
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported a blown fuse of an electrosurgical irrigator (id 90100irro).Issue detected before surgery.No patient consequences, no surgical delay.No additional information available.
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.
Additional Manufacturer Narrative
The electrosurgical irrigator was returned for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the irrigator unit was inspected by the service technician.The technician found that the fuses had blown and needed to be replaced.The irrigator functioned as intended once the fuses were replaced.The complaint could be verified through failure analysis.Root cause - root causes include loss of regulation from the upstream power supply, or short circuit between primary winding and secondary winding in auxiliary power supply due to overheating.The complaint was confirmed in the complaint investigation.
Event or Problem Description
N/a.

• Brand Name: ELECTROSURGICAL IRRIGATOR
• 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: 17272941
• Report Number: 3014334038-2023-00102
• Device Sequence Number: 5296986
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

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: Health Professional
• Device Catalogue Number: 90100IRRO
• Device Lot Number: RRG2119015
• 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: 06/13/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2021
• 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