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

Catalog Number PPH03

Device Problem Defective Component (2292)

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

Event Date 06/02/2015

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, the device did not work because of a poor handle firing.It is unknown how the procedure was completed.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4).At the time of this submission, the device has not been returned for analysis.If the device is received at a later date a supplemental medwatch will be sent.Additional information received: please verify the lot number of the device.The lot number provided is invalid.Sorry lot number m52514.Please clarify what is meant by, the device did not work because of a poor handle firing.This is not clear.This hospital doctors has done hemo surgery over 1000 case.The handle was pushed but handle did not move.This hospital surgeons used.What type of procedure was the device being used in? hemo surgery.How was the procedure completed? exchanged new pph03.

Manufacturer Narrative

(b)(4).Batch # m52514.The analysis results found that the pph03 device arrived with the handles open; due to insufficient handle weld.The breakaway washer was present and cut and there were no staples present, indicating that the device achieved a full firing stroke.The device was reloaded with staples, a new washer was placed on the device and it was tested for functionality.It fired and formed all the staples as well as completely cut the test media and the breakaway washer without incident.The staple line was complete and the staples were noted to have the proper b-formed shape.A batch record review was performed and no anomalies were found during the manufacturing process.

• Brand Name: PROXIMATE PROCEDURE 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 ; 5133378865
• MDR Report Key: 4847691
• MDR Text Key: 5872089
• Report Number: 3005075853-2015-03590
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K051301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/03/2015

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: 12/17/2019
• Device Catalogue Number: PPH03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2015
• Initial Date FDA Received: 06/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2015
• 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