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

Catalog Number UV120

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information asked for but unknown or not provided during initial contact.Information anticipated, but unavailable at this time.When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.Week of (b)(6) 2015.

Event Description

It was reported that prior to an unknown laparoscopic procedure, the tyvek packaging of the device did not have any print on it.The device was not used in the procedure and the packaging was saved.The remaining devices in the sales unit were inspected and all other packaging was noted to be normal, without issue.Another device of the same product code and from the same sales unit was used to complete the procedure.There were no adverse consequences for the patient.

Manufacturer Narrative

Tracking (b)(4).Result: upon visual inspection of the tyvek lid, it was confirmed that no variable or nonvariable print was present to verify product code or lot, but the tyvek had evidence that i had been sealed to a blister package of the proper size and shape, and indications were that it was most likely from a uv120 package.The mh2 machine that was used to package the uv120 requires two different printers.The multi-lane thermal transfer printer places the variable info that includes the lot number and the use by date.The gottcho printer places the non-variable info that includes the product code, description, and remaining details onto the tyvek lid.Both printers are in operation during production.The machine prints four each per cycle.Only one package with missing print has been reported.Quality inspection records were checked and no anomalies were noted.The product met all in-process and finished goods specs prior to release.Machine long books info were checked and no anomalies were noted during production of lot m4j049.Equipment testing was performed as part of the investigation.The equipment testing was able to create this defect when the top stock change and material splicing method is done in a specific way.The secondary root cause is human error; associate at sort failed to defect the blank tyvek.The lot records were reviewed: no protocols, defects, non-conformances or quarantine noted.The product met all in-process and finished goods specs upon release of the product.

• Brand Name: ULTRA VERESS 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: 5223582
• MDR Text Key: 31385500
• Report Number: 3005075853-2015-07357
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2015

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: 07/31/2020
• Device Catalogue Number: UV120
• Device Lot Number: M4J049
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/02/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 11/13/2015
• Supplement Dates Manufacturer Received: 02/18/2016
• Supplement Dates FDA Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1