MAUDE Adverse Event Report: MICROLINE SURGICAL INC. DISPOSABLE 19 MEDIUM/LARGE TITANIUM K2 CLIP CART; CLIP IMPLANTABLE

Model Number 1112

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.

Manufacturer Narrative

Three devices were returned and visually inspected.One device was returned in the original packaging unopened.(b)(4) the second device was returned stuck inside a returned hand piece (b)(4).The clip cartridge was damaged and impossible to remove from the device.Because of the condition of the returned cartridge a thorough product investigation of the cartridge was not possible.The cartridge was lodged into the clip applier, and impossible to remove.Therefore a functional examination of the cartridge was not possible.Visual observation of the exposed part of the clip cartridge, indicate that the cartridge was extremely damaged.The clip applier was returned with damages to the hand piece and bar feeder that looked to be the result of excessive force or stress.The type of force that the hand piece and cartridge experienced have been noted before.These kind of damages that will cause a mechanical jam and or a defective application of the product.This complaint is confirmed.Ref: 1223422-2017-00132, 1223422-2017-00133, 1223422-2017-00134, 1223422-2017-00135.

• Brand Name: DISPOSABLE 19 MEDIUM/LARGE TITANIUM K2 CLIP CART
• 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: 7013598
• MDR Text Key: 92643159
• Report Number: 1223422-2017-00134
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was 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 Expiration Date: 10/28/2021
• Device Model Number: 1112
• Device Catalogue Number: 1112
• Device Lot Number: 00130788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2016
• 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