MAUDE Adverse Event Report: MICROLINE SURGICAL INC RENEW L-HOOK CAUTERY TIP, DISPOSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENT

Model Number	6172
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was intially reported to microline surgical by health canada.Currently, the vendor in canada (amt electrosurgical) is being contacted to try and get more information from the customer (mackenzie health) about the event, outcome, if the device is available for testing, etc.Once more information is provdided, a follow-up report will be submitted.
Event or Problem Description
While performing cauterization, there was a spark at the cautery tip/ joint of handle.Minor burn on liver from cauterization tip in same operative site.

• Brand Name: RENEW L-HOOK CAUTERY TIP, DISPOSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENT
• Manufacturer (Section D): MICROLINE SURGICAL INC; 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: 19125643
• Report Number: 1223422-2024-00012
• Device Sequence Number: 7647812
• Product Code: GEI
• UDI-Device Identifier: 00811099010876
• UDI-Public: 00811099010876
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K981188
• 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
• Report Date (Section B): 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6172
• Device Catalogue Number: 6172
• Device Lot Number: 00169919
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 04/17/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown