MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD ELECTROSURGICAL IRRIGATOR

Model Number	901001IRRO
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported an electrosurgical irrigator with a defective fuse.Product was in contact with the patient; however, no patient injury was reported and the event led to 30 minutes surgical delay.
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 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 analyst checked the fuses with a fluke multimeter and discovered the fuses were open, confirming that they were blown fuses.The fuses were replaced with known good fuses and the irrigator performed as intended.Root cause - the complaint was confirmed in the complaint investigation.Fuses in the irrigator were found to be blown.When run with known good fuses, the irrigator performed as intended.The likely root cause of this failure is blown fuses.
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: 13694670
• Report Number: 3014334038-2022-00035
• Device Sequence Number: 1943760
• Product Code: GEI
• UDI-Device Identifier: 10886704081692
• UDI-Public: 10886704081692
• Combination Product (Y/N): N
• PMA/510(K) Number: K182801
• 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): 08/11/2022

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: 901001IRRO
• Device Catalogue Number: 90100IRRO
• 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: 02/11/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2019
• 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