MAUDE Adverse Event Report: MICROLINE SURGICAL INC. RENEW SUPER ATRAUMATIC GRABBER TIP, DISPOSABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACC

Model Number	3622
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, decontaminated and visually investigated.Upon visual inspection, this complaint has been confirmed.The returned tip was received with a loose heat shrink.During visual inspection, slight damages were noted on distal end to the tip.No signs of arcing or thermal damages were noted on the device.The minor damages observed on the heat shrink, line up very close to the hinge point of the jaws.For final inspection requirements, all devices are 100% inspected for damages and imperfections.This complaint is confirmed.We were unable to determine the root cause.
Event or Problem Description
The heat shrink of the atraumatic grasper tip fell off into the patient.The piece was retrieved.The anesthesia time was not extended and there was no harm to the patient.

• Brand Name: RENEW SUPER ATRAUMATIC GRABBER TIP, DISPOSABLE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACC
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 7537066
• Report Number: 1223422-2018-00014
• Device Sequence Number: 1899075
• Product Code: GEI
• UDI-Device Identifier: 00811099010142
• UDI-Public: 00811099010142
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K981389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2018

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 Expiration Date: 10/28/2022
• Device Model Number: 3622
• Device Catalogue Number: 3622
• Device Lot Number: 00137857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1