MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD SUCTION COAG W/L-HOOK END INS; ELECTROSURGICAL COAGULATION

Model Number	600305
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This is 2 of 2 reports and is related to mfg report number 3014334038-2023-00043: it was reported that the insulation of the suction coag w/l-hook end ins (600305) was ¿melting¿ at the instrument end.It is unknown under what circumstance this event occurred; however, no harm or surgical delay was reported.
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 suction coag w/l-hook end ins (600305) was not returned to the manufacturer; therefore, an evaluation of the actual device could not be performed.Lot number information has been provided, device history record (dhr) was reviewed and no abnormalities related to the reported issue were identified.The complaint reported by the customer was confirmed.Per visual evaluation of provided images, the l-shaped hook suction coagulator had heat/melting damage at the end of the insulation.This type of damage may be the result of high heat setting or prolonged use.Per the instructions for use (ifu), "for electrosurgical instruments, use the least amount of power appropriate for the application".No manufacturing, workmanship or material deficiency has been identified.

• Brand Name: SUCTION COAG W/L-HOOK END INS
• Common Device Name: ELECTROSURGICAL COAGULATION
• 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: 16684105
• Report Number: 3014334038-2023-00039
• Device Sequence Number: 12588323
• Product Code: KNF
• UDI-Device Identifier: 10381780129400
• UDI-Public: 10381780129400
• Combination Product (Y/N): N
• PMA/510(K) Number: K932456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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: Other
• Device Model Number: 600305
• Device Catalogue Number: 600305
• Device Lot Number: AB2212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/03/2023
• Date Device Manufactured: 12/01/2022
• 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