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

Model Number 1122J

Device Problem Defective Component (2292)

Patient Problem Perforation of Vessels (2135)

Event Date 06/15/2021

Event Type  malfunction  

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 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
• Type of Device: IMPLANTABLE CLIP
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• Manufacturer (Section G): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• Manufacturer Contact: scott marchand davis ; 50 dunham road; suite 1500; beverly, MA 01915 ; 9789229810
• MDR Report Key: 12226120
• MDR Text Key: 265586683
• Report Number: 1223422-2021-00002
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00811099012337
• UDI-Public: 00811099012337
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 1122J
• Device Catalogue Number: 1122J
• Device Lot Number: 00154789
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2021
• Initial Date FDA Received: 07/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1