MAUDE Adverse Event Report: MICROLINE SURGICAL INC. ML-10 MUTI-FIRE CLIP APPLIER CLIP IMPLANTABLE

Model Number 1002

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/24/2017

Event Type  Malfunction  

Manufacturer Narrative

Product not returned. No investigation can be performed at this time.

Event Description

During a surgical cholecystectomy, the surgeon attempted to fire a clips and experienced a mechanical jam. The procedure and anesthesia time was extended for 20 minutes. There was no harm to the patient.

• Brand Name: ML-10 MUTI-FIRE CLIP APPLIER
• Type of Device: CLIP IMPLANTABLE
• 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: anu gaur ; 50 dunham road; suite 1500; beverly, MA 01915 ; 9789229810
• MDR Report Key: 7013618
• MDR Text Key: 92649084
• Report Number: 1223422-2017-00132
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (Y/N): N
• Reporter Country Code: EG
• PMA/PMN Number: K013695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: USER FACILITY

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 11/09/2017
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 1002
• Device Catalogue Number: 1002
• Device LOT Number: 00133658
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/13/2017
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 04/21/2017
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown