MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ROTATING MULTIPLE CLIP APPLIER; CLIP, IMPLANTABLE

Catalog Number ER320

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2014

Event Type  malfunction  

Event Description

It was reported that prior to an unknown procedure, both devices the clips bifurcated during the first trial fire, after taken out of the package.It is unknown what was used to complete the procedure.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4).Information was not provided by the contact.Information anticipated, but unavailable at this time.

Manufacturer Narrative

(b)(4).Additional information: the analysis results of the er320 device found that it was received in good condition.A bag with one conforming clip and five scissored clips was returned along with the instrument.In an attempt to replicate the reported incident, the device was tested for functionality.During the analysis, the device was cycled and it fed and formed fourteen scissored clips; in addition, the device locked out as intended.Although it is not possible to conclude how the circumstances occurred, it is known from the history of the instrument that an incorrect/excessive application of torque to the jaws during instrument use creates a misalignment of the tips.In addition as per the instructions for use ¿do not excessively twist or torque the instrument jaws when positioning the instrument on a vessel and firing.Excessive twisting or torquing may result in clip malformation¿.The batch record was reviewed and no anomalies were noted during the manufacturing process.

• Brand Name: ROTATING MULTIPLE CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): DEFAULT ORGANIZATION; 4545 creek rd ml # 36; cincinnati OH 45242 280
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4402435
• MDR Text Key: 5429944
• Report Number: 3005075853-2015-00252
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K864102
• 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,Followup
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2019
• Device Catalogue Number: ER320
• Device Lot Number: L4ET2W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2014
• 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