MAUDE Adverse Event Report: MICROLINE SURGICAL INC. M/L-10 MULTI-FIRE CLIP APPLIER, REUSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENTS

Model Number	1002
Medical Device Problem Codes	Material Deformation (2976); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	04/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned to the manufacturer.An investigation is not possible at this time.
Event or Problem Description
The clip did not load properly on first use of the clip applier.The jaws closed without a clip in place and cut off the cystic duct; the procedure time was not extended.
Additional Manufacturer Narrative
The device was returned, decontaminated and visually inspected for any signs of physical damage.No signs of physical damages were observed on the device.The jaws of the returned clip applier were measured to be out of spec.This is a clear indication that the jaws of the device have experienced excessive force.If jaws of the device are activated on hard material such as another clip, or used outside of its intended use in any way, the dimensions of the jaws will be compromised.If a cartridge was inserted and the end user did not look at the tip of the jaws for and open clip before attempting to use on a vesicle and the jaws were activated, the jaws of the device will act like a scissor and could cause damages to the patient.For final inspection requirements, all devices are 100% inspected for damages and imperfections.It is not likely that the device left microline inc in this condition.The type of damages observed are the result of excessive force to the jaws of the device.
Event or Problem Description
The clip did not load properly on first use of the clip applier.The jaws closed without a clip in place and cut off the cystic duct;.The procedure time was not extended.

• Brand Name: M/L-10 MULTI-FIRE CLIP APPLIER, REUSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENTS
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 8646944
• Report Number: 1223422-2019-00012
• Device Sequence Number: 2017450
• Product Code: GCJ
• UDI-Device Identifier: 00811099010388
• UDI-Public: 00811099010388
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2019

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: 1002
• Device Catalogue Number: 1002
• Device Lot Number: 00143111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other