MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 0 S/A UR-6; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	D7185
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # :(b)(4).H6 component code: g07002 - device not returned.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained via: here was no known adverse consequences associated with the patient so far.Re adverse consequence associated with the injured nursing staff member: - there is a 3 months window observation period for infection therefore outcome will not be conclusive till the 3 months is up.Re operation where the 0 pds atraumatic was detached & stuck inside patient¿s cavity: there was nil known complication as a result of the prolonged surgery time up-to-date.The tissue being sutured was lodged between layers of fat.No additional dissection was required on other tissue other than targeted tissue, although surgeon had to use a pair of artery to dig through the fat to look for and retrieve the needle.The operation was prolonged because of it.But we do not have a record of the exact minute count.There was no known change in post op care related to the prolonged operation.Re complaints on ¿multiple cases that happened across different specialties¿: i had at least 10 scrub or scout nurses reporting the problem of difficulty in pulling sutures out of inner packages.Specialties involved include colorectal, urology, robotic, general, gynaecology & orthopaedics.Unable to provide exact number or specifications of cases as they were retrospective feedbacks and no adverse effect on patient was known at the time.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2023 and suture was used.During the procedure, the 0 pds atraumatic was detached & stuck inside patient¿s cavity.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/14/2023.H6 component code: g07002 no device problem found.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.The returned sample determined that it was received, thirteen sealed samples that pertain to product code d7185.In the inspection of the returned samples, the packets were opened and were tested to verify the dispensability of the sutures, and the sutures were dispensed without problems.A functional test was performed using instron equipment, and the pull force results were above the minimum requirements.As part of the ethicon 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PDSII VIO 27IN 0 S/A UR-6
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17413983
• Report Number: 2210968-2023-05475
• Device Sequence Number: 7135421
• Product Code: NEW
• UDI-Device Identifier: 10705031027343
• UDI-Public: 10705031027343
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2023

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: D7185
• Device Lot Number: SKMMEB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 08/24/2023; 09/12/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 09/14/2023; 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown