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

Catalog Number	UV120
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 10/16/2024 d4: batch # unk attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: "which portion of the packaging was damaged (tyvek, plastic/blister, white outer box, etc.)? was sterility compromised as a result of the packaging damage?" investigation summary the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the uv120 device was returned inside it's original packaging unopened.Upon visual inspection, it was observed that the tyvek from the packaging was damaged; it was noted to have a hole in the tyvek, the hole was noted to be from the outside in.The event reported was confirmed and it is related to improper use of the device.Due to the damages found on the packaging, a possible cause for these conditions is due to improper handling during transit or storage; it appears that the package hit a pointy surface and this caused the reported event.A manufacturing record evaluation was performed for the finished device number, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure, package is damaged.No patient consequences.

• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 20467150
• Report Number: 3005075853-2024-07811
• Device Sequence Number: 15356729
• Product Code: HIF
• UDI-Device Identifier: 10705036013426
• UDI-Public: (01)10705036013426(17)280731(10)585C19
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K983925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/16/2024

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 Catalogue Number: UV120
• Device Lot Number: 585C19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown