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

Model Number UV120

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

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 was confirmed.Due to the damage 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.

Event 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.

• Type of Device: 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 ; *
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 12662633
• MDR Text Key: 277353244
• Report Number: 3005075853-2021-06299
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 10705036013426
• UDI-Public: 10705036013426
• Combination Product (y/n): N
• PMA/PMN Number: K983925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1