MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE HCS PPH SET; STAPLE, IMPLANTABLE

Catalog Number PPH03

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What type of procedure was the device used in? please describe how the device was ¿defective during use.¿ the analysis results found that the pph03 device arrived with the knife damaged; the breakaway washer was present and with an off-center cut.It appears possible that the anvil was pushed far enough off center to result in an off center cut of the breakaway washer and damage the knife by pressing it hard enough against the anvil.In addition the guide face was noted to be damaged.This situation normally occurs when the tissue is not evenly distributed in the device.However, it could not be determined what may have caused the anvil to become off center.It should be noted that ensuring that the tissue thickness is within the indicated range, and that it is evenly distributed in the device.Excess tissue on one side may result in unacceptable staple formation and can result in staple line leakage.Please reference the instructions for use for additional information.No functional test was performed due to the condition of the device, as the damage on the guide face does not allow the device to function as intended.The batch history record was reviewed and no protocols or ncr related to the complaint were found during the manufacturing process.

Event Description

It was reported that during an unknown procedure, the device was defective during use.Another like device was used to complete the procedure.There were no adverse consequences for the patient reported.

• Brand Name: PROXIMATE HCS PPH SET
• Type of Device: STAPLE, 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: 5969554
• MDR Text Key: 55332409
• Report Number: 3005075853-2016-05379
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K051301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/29/2016

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: 04/30/2021
• Device Catalogue Number: PPH03
• Device Lot Number: N91E80
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1