MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 0 S/A CT-2; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z334H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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 a robotic assisted total hysterectomy procedure on (b)(6) 2021 and suture was used.During the procedure, the needle popped off while tying a knot at the end of the suture line.No additional sutures were needed to complete the procedure.There were no adverse consequences for the patient.No additional information was provided.

• Brand Name: PDSII VIO 27IN 0 S/A CT-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12144199
• Report Number: 2210968-2021-06170
• Device Sequence Number: 11756101
• Product Code: NEW
• UDI-Device Identifier: 10705031060562
• UDI-Public: 10705031060562
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

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: 03/31/2026
• Device Model Number: Z334H
• Device Catalogue Number: Z334H
• Device Lot Number: RDMBDH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/09/2021
• Patient Sequence Number: 1