MAUDE Adverse Event Report: MICROLINE SURGICAL, INC. M/L-10 MULTI FIRE CLIP APPLIER; LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS

Model Number 1002

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer by the user facility/hospital for investigation.There was no harm to the patient.Reference: (b)(4) [initial report submitted by user facility].

Event Description

During a laparoscopic cholecystectomy procedure, the ml-10 clip applier (#1002) jammed while in use with the clip cartridge (#1112) clip cartridge.There was no harm to the patient.Hospital narrative submitted to fda on 11/04/2016 (b)(4).

• Brand Name: M/L-10 MULTI FIRE CLIP APPLIER
• Type of Device: LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS
• Manufacturer (Section D): MICROLINE SURGICAL, INC.; 50 dunham road; suite 1500; beverly MA 01915
• Manufacturer Contact: anu gaur ; 50 dunham road; suite 1500; beverly, MA 01915 ; 9789229810
• MDR Report Key: 6136847
• MDR Text Key: 61502795
• Report Number: 1223422-2016-00034
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61.0 YR