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

Catalog Number PN120

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information asked for but unknown or not provided during initial contact.No device received for analysis at time of submission of 3500a.When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.

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).Conclusion: the devices that were returned were not the device used.No conclusion could be reached or the complaint confirmed without the needle that was used returned for analysis.We did not receive a valid batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformances.

• Brand Name: PNEUMOPERITONEUM INSUFFLATION NEEDLE
• 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: 4929608
• MDR Text Key: 22567267
• Report Number: 3005075853-2015-04454
• 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: company representative,user f
• Reporter Occupation: Other
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1