MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH INSUFFLATION NEEDLE; APPARATUS, PNEUMOPERITONEUM, AUTOMATIC

Catalog Number PN120

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2014

Event Type  malfunction  

Event Description

It was reported that before an unknown procedure, the needle did not retract when it was tested prior to being used on the patient.There were no patient consequences.Case completed with another device of the same product code.

Manufacturer Narrative

(b)(4).Information anticipated, but unavailable at this time.

Manufacturer Narrative

(b)(4).Additional information: based upon the visual and functional examination, it was concluded that the device is conforming.Analysis was unable to confirm the customer's complaint.The needle functions normally.The device record was reviewed and no anomalies were noted during the manufacturing process.

• Brand Name: ENDOPATH INSUFFLATION NEEDLE
• Type of Device: APPARATUS, PNEUMOPERITONEUM, AUTOMATIC
• 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: 4098565
• MDR Text Key: 4764354
• Report Number: 3005075853-2014-06494
• Device Sequence Number: 1
• Product Code: FDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PN120
• Device Lot Number: L4EP5N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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