MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*ULTRAVERES NDL 120MM; INSUFFLATOR, LAPAROSCOPIC

Catalog Number	UV120
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 05/31/2019.Unknown, assumed 1st day of month that complaint was reported.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
Event or Problem Description
It was reported that the packaging was compromised (semi-open) sterilization.We report that there was no adverse event.

• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8658263
• Report Number: 3005075853-2019-19424
• Device Sequence Number: 19305010
• Product Code: HIF
• UDI-Device Identifier: 10705036013426
• UDI-Public: 10705036013426
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K983925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: UV120
• Device Lot Number: N4LU0D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 05/31/2019
• Patient Sequence Number: 1