MAUDE Adverse Event Report: MICROLINE SURGICAL RENEW CAUTERY TIP, SPATULA, DISPOSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENT

Model Number	6182
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was initally reported to the fda by the hospital ( (b)(6) hospital) under user report #1402310000-2023-8016 and was given the report number (b)(4) in the fda maude database.When this event was first reported to microline surgical back in (b)(6) 2023, it was not clear that there was patient involvement.On april 09, 2024, it was realized that there was patient involvement and mfr report was created.However, no invetstigation could be conducted as the product was never returned to msi, and it is not expected to be returned.
Event or Problem Description
During a laparoscopic cholecystectomy, surgeon was using a spatula cautery tip for coagulation and when the scrub tech was cleaning the char off the tip, she noticed that the plastic coating of the spatula was peeling.The nurse opened a replacement tip and after the first use, the same thing occurred with the spatula tip.The tips were removed from patient care and turned into the specialty leader for further inspection.

• Brand Name: RENEW CAUTERY TIP, SPATULA, DISPOSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENT
• Manufacturer (Section D): MICROLINE SURGICAL; 50 dunham rd suite 1500; beverly MA 01915
• Manufacturer (Section G): MICROLINE SURGICAL INC; 50 dunham rd suite 1500; beverly MA 01915
• Manufacturer Contact: scott marchand davis ; 50 dunham rd suite 1500; beverly, MA 01915 ; 9789229810
• MDR Report Key: 19075745
• Report Number: 1223422-2024-00009
• Device Sequence Number: 12468936
• Product Code: GEI
• UDI-Device Identifier: 00811099010883
• UDI-Public: 00811099010883
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K981188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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: 6182
• Device Catalogue Number: 6182
• Device Lot Number: 00168529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 18282668
• Patient Sequence Number: 1
• Patient Sex: Male