MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PNEUMOPERITONEUM INSUFFLATION NEEDLE

Catalog Number PN120

Device Problem Retraction Problem (1536)

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

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, the device was not retracting and the red part at the top of the device was showing.The surgeon was concerned the device could puncture bowel.Another device was used to complete the procedure.There were no adverse consequences for the patient.

Manufacturer Narrative

(b)(4): information not available, device not returned for analysis.Should the information be provided later, a supplemental medwatch will be sent.

• Brand Name: PNEUMOPERITONEUM INSUFFLATION NEEDLE
• Type of Device: INSUFFLATION NEEDLE
• 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: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 4892700
• MDR Text Key: 20070785
• Report Number: 3005075853-2015-04071
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2015
• 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: M4HL6R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1