MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP MCA MED LONG; CLIP, IMPLANTABLE

Catalog Number MCM30

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 05/22/2014

Event Type  malfunction  

Event Description

It was reported that prior to an unknown procedure, the clips drop automatically from the devices.It is unknown how the procedure was completed.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4).Lockout premature, damaged latch post, jaw misaligned.The analysis results found that the mcm30 device was returned in good visual condition.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, the device was cycled, fed, and formed the remaining 1 clip as intended.The device was found to be fully functional and conforming to our manufacturing specifications.In addition, one malformed clip was received inside a sample bag.No conclusion could be reached as to what may have caused the reported incident or the received malformed clip.The batch record was reviewed and no anomalies were noted during the manufacturing process.

• Brand Name: LIGACLIP MCA MED LONG
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3907176
• MDR Text Key: 4670761
• Report Number: 3005075853-2014-04556
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2014

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 Expiration Date: 10/16/2018
• Device Catalogue Number: MCM30
• Other Device ID Number: BATCH # K92R0Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2014
• Initial Date FDA Received: 07/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2013
• 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