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

Model 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	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unk.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Upon visual analysis of the returned sample, it was determined that the uv120 device was returned with its packaging.The boxes were visually inspected and they were bent and damaged.Upon visual inspection, it was observed that the tyvek from the packaging was damaged (holes).The damage found compromised the device's sterility.The damage observed on the package was most likely caused due to damage noted on the boxes.The reported event is confirmed.Due to the damages found on the packaging, a possible cause for this condition is due to improper handling during transit or storage.It appears that the package hit a hard surface, and this caused the reported event.Please reference the instructions for use for more information.As part of our quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Additional information received: three photos were received for review.During the visual analysis, the following was observed: the first photo showed an ethicon endo surgery box damaged from a corner and appears to be a tyvek inside with the product code number uv120.The second photo shows the box belongs to a 12mm ultra veress device.The box was observed to be damaged.The third photo showed a device inside of its packaging with no apparent damage.Based on the three photos reviewed, the event described was confirmed, however no conclusion or root cause could be determined.Please refer to the device analysis for full analysis details and conclusion.As part of our quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of our post market surveillance.
Event or Problem Description
It was reported that during an unknown procedure, the packaging was discovered to be damaged.It is unknown how the procedure was completed.There was no patient consequence.

• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 12661903
• Report Number: 3005075853-2021-06289
• Device Sequence Number: 4211520
• Product Code: HIF
• UDI-Device Identifier: 10705036013426
• UDI-Public: 10705036013426
• Combination Product (Y/N): N
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2021

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: 05/31/2026
• Device Model Number: UV120
• Device Catalogue Number: UV120
• Device Lot Number: 348A16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 10/19/2021
• Patient Sequence Number: 1