MAUDE Adverse Event Report: MICROLINE SURGICAL INC. M/L-10 CLIP CARTRIDGE, 10 CLIPS, DISPOSABLE; CLIP IMPLANTABLE

Model Number	1122
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two clips were returned, and visually investigated.Upon visual inspection, this complaint has been confirmed.During the investigation, the clips looked to be deformed, and not in the typical formation of a fired clip.One clip was returned as if it was fired from a clip applier with scissoring jaws.The other was returned not fully crimped.This clip was blue, this is an indication that the clip applier may have fired all but 2 clips.This complaint is confirmed.However, because the device that fired this clip was not returned it is impossible to determine the root cause.A lot history search was conducted on the associated lot number.No other complaints were found.This was an isolated incident.
Event or Problem Description
During a surgical procedure, the surgeon noticed that the clips did not form as the should.The ml-10 clip applier released a deformed scissored clip.The final blue clip was fully crushed but stuck to one side of the jaw.The procedure was extended by 5 mins.There was no harm to the patient.

• Brand Name: M/L-10 CLIP CARTRIDGE, 10 CLIPS, DISPOSABLE
• Common Device Name: CLIP IMPLANTABLE
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 7806353
• Report Number: 1223422-2018-00023
• Device Sequence Number: 19241815
• Product Code: GCJ
• UDI-Device Identifier: 00811099010470
• UDI-Public: 00811099010470
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K013695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2018

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: 04/28/2023
• Device Model Number: 1122
• Device Catalogue Number: 1122
• Device Lot Number: 00140271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1