MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 30IN 3-0 D/A SH; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	X562H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.(b)(4).To date it has been reported that the device will not be returned.If the device or further details are received as a later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: were there any unexpected outcomes or complications as a result of the prolonged surgery time? no further information is available.What tissue was being sutured when the event occurred? no further information is available.Was additional dissection required in other organs/tissues other than the target tissue? no further information is available.Was there any change in the patient¿s post operative care due to the prolonged procedure? no further information is available.Was the needle retrieved during the same procedure? yes.Were x-rays taken to locate the needle? no further information is available.Was there any additional tissue damage as a result of searching for the needle? no further information is available.We were reported that the case did not become a serious injury.No further information will be provided.
Event or Problem Description
It was reported that a patient underwent a laparoscopic sacral hysterectomy on an unknown date and suture was used.During the procedure, when the surgeon tried to remove the needle from the laparoscope, the needle was detached from the suture in the trocar and fell into the abdominal cavity.The surgeon did not notice it when the suture was retrieved, and 4 to 5 minutes later, a scrub nurse noticed it.After that, the surgeon searched the abdominal cavity for several minutes and found the needle.The operation time was extended within 30 minutes.There were no adverse consequences to the patient.No additional information was provided.

• Brand Name: EB EXC GRN 30IN 3-0 D/A SH
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16157964
• Report Number: 2210968-2023-00319
• Device Sequence Number: 7507370
• Product Code: GAT
• UDI-Device Identifier: 10705031057609
• UDI-Public: 10705031057609
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946173
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/13/2023

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 Expiration Date: 04/30/2026
• Device Model Number: X562H
• Device Catalogue Number: X562H
• Device Lot Number: REMPLH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2021
• 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