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

Model Number UV120

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 03/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Attempts are being made to retrieve the device.To date, no additional information has been received and no device has been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a laparoscopy procedure, the doctor reported that the disposable (device) was damaged (bent) inside the packaging and the safety mechanism was not working.The product was replaced and did not cause damage to the patient.

Manufacturer Narrative

(b)(4).Date sent: 9/13/2021 investigation summary: the product was returned for evaluation.In addition, a tyvek wrapper was also received.Visual inspection was conducted on the returned device.Upon visual analysis of the returned sample, it was determined the uv120 device was returned with the needle sleeve bent.Due to the condition of the device, the blunt safety stylet was jammed in the needle and no functional test could be performed.It should be noted that product failure is multifactorial.The event reported was confirmed and it is related to improper use of the device.One possible cause for the damage found on the needle sleeve may be due to excessive force being applied.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.

• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 11240869
• MDR Text Key: 229113228
• Report Number: 3005075853-2021-00496
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

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
• Device Operator: Health Professional
• Device Model Number: UV120
• Device Catalogue Number: UV120
• Device Lot Number: T40U4Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 08/23/2021
• Supplement Dates FDA Received: 09/13/2021
• Patient Sequence Number: 1
• Patient Age: 43 YR