MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PNEUMOPERITONEUM INSUFFLATION NEEDLE - 120MM LENGTH

Catalog Number PN120

Device Problems Retraction Problem (1536); Device Operates Differently Than Expected (2913)

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

Event Date 07/17/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a laparoscopic gynecologic procedure, as the device entered the abdomen, the first click was heard but there was no subsequent second click and the sheath had not retracted back to cover the needle tip.It is not known how the procedure was completed.There were no adverse consequences for the patient reported.

• Brand Name: PNEUMOPERITONEUM INSUFFLATION NEEDLE - 120MM LENGTH
• 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: 4957862
• MDR Text Key: 23230282
• Report Number: 3005075853-2015-04757
• Device Sequence Number: 1
• Product Code: FDP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K910875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• 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: M4HD0G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2015
• 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