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	Serious Injury
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
A clip applier was used during a surgical procedure.A second operation was required 5 days later and a wound was observed on the cystic duct.There was a necrotic wound located next to a normally placed clip.
Additional Manufacturer Narrative
The device was returned, decontaminated and visually investigated.During visual inspection, it was noticed that the jaws were misaligned when fully closed.This is an indication that the device had been used outside of its intended use.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.The jaws of the device also over lapped, causing the finish position of the actuated device to look that of a scissors.Next the device was tested for functionality.A new clip cartridge was inserted into the device and the device trigger was fired.This complaint is confirmed.Upon firing the device the clip was not fully held by the jaws of the device, causing the alignment of the the release of the clip to be off.As the next clip was fired the device jammed due to the damaged jaws.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.
Event or Problem Description
A clip applier was used during a surgical procedure.A second operation was required 5 days later and a wound was observed on the cystic duct.There was a necrotic wound located next to a normally placed clip.

• 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: 8646947
• Report Number: 1223422-2019-00013
• Device Sequence Number: 16608803
• 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: 00127030
• 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: Required Intervention