MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PDS CORD; CLIP, IMPLANTABLE

Catalog Number ER320

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information anticipated, but unavailable at this time.When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.Additional information was requested and the following was obtained: what is meant by clips not seating properly? customer said they would not close all the way.Did clips not feed into jaws or partially feed? n/a.Did clips feed sideways? n/a.Did clips slow feed? n/a.Did multiple clips feed? customer said a few fires multiple clips were fed.

Event Description

It was reported that during an unknown procedure, the customer said that the clips were not seating properly.An er420 device was used to complete the procedure.There were no adverse consequences for the patient.

Manufacturer Narrative

(b)(4).Should the information be provided later, a supplemental medwatch will be sent.Batch # m90v8l.The er320 device was returned for analysis and upon inspection the jaws were found to be in a yielded condition.In an attempt to replicate the reported incident the device was functionally evaluated.Upon firing of the device, the remaining clips were ejected due to the condition of the jaws; finally the instrument locked out as intended.Possible causes for the found condition of the yielded jaws may be if the device is closed over an existing hard object or clip placing stress on the jaws causing them to distort or yield and not return to their original dimensions/position or excessive application of torque to the jaws when positioning the device on a vessel.The batch record was reviewed and no anomalies were noted during the manufacturing process.

• Brand Name: PDS CORD
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5026047
• MDR Text Key: 24780502
• Report Number: 3005075853-2015-05280
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2020
• Device Catalogue Number: ER320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1