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

Model Number	1122J
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, decontaminated, visually inspected and lab evaluated.After evaluation the complaint is confirmed.The device was returned with no visual defects, and during "dry" functional testing without clips the device appears to be working correctly.When the clip cartridge which was returned with handpiece was tested in the device, the two remaining clips in the cartridge did not dispense cleanly.They crushed in the jaws but then did not fully dispense, somewhat sitting in the pocket of one of the jaw.When a new clip cartridge was inserted, this issue did not occur and all the clips were dispensed without issue.The complaint is confirmed, however the issue more likely stems from the clips in this returned cartridge.Root cause is a clip dimensional/surface finish issue.Either a slight dimension out of spec or a surface finish causing the clips to "stick" in the jaws.Without additional clips from this specific cartridge/lot it is difficult to determine exact root cause.
Event or Problem Description
Vessel was hurt and bleeding occurred because the surgeon pulled the handpiece as he thought the clip was successfully clipped which actually was not.

• Brand Name: M/L-10 CLIP CARTRIDGE, 10 CLIPS, JAPAN USE
• Common Device Name: IMPLANTABLE CLIP
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 12226120
• Report Number: 1223422-2021-00002
• Device Sequence Number: 17061528
• Product Code: FZP
• UDI-Device Identifier: 00811099012337
• UDI-Public: 00811099012337
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2021

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: 12/28/2025
• Device Model Number: 1122J
• Device Catalogue Number: 1122J
• Device Lot Number: 00154789
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1