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

Model Number 6172

Device Problem Sparking (2595)

Patient Problem Burn(s) (1757)

Event Date 03/09/2024

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 340471821
• Report Number: 1223422-2024-00012
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00811099010876
• UDI-Public: 00811099010876
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K981188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 6172
• Device Catalogue Number: 6172
• Device Lot Number: 00169919
• Initial Date Manufacturer Received: 04/17/2024
• Initial Date FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1