MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 8X18IN 1 S/A CT-1 CR; SUTURE, ABSORBABLE, NATURAL

Model Number	CC40G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Voluntary report: medwatch form mw4600210000-2021-8007.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: could you please confirm the quantity of devices in which needle release from suture during use on the patient was observed? we went through 4-6.I believe we had 2 packages on the field.How long was the delay? i had additional packages in the room so the delay was not too long.Just a few minutes with the defective control release and the time it took me to open additional packages.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? no unexpected outcomes i was made aware of.They required replacement sutures at the time to complete what they were currently doing.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the reported complaint condition were identified.Note: events reported via 2210968-2021-07560, 2210968-2021-07565, 2210968-2021-07561, 2210968-2021-07563 and 2210968-2021-07564.
Event or Problem Description
Per user facility medwatch form mw4600210000-2021-8007.It was reported that a patient underwent a lap assist vaginal hysterectom procedure on (b)(6) 2021 and suture was used.During the procedure, as the surgeon was pulling through the tissue, the needle released from the suture requiring a different one to be used.Several attempts with different packages resulted in the same failure mode.Another like device was used to complete surgery without further issue.The surgical procedure was delayed due to the multiple incidents with the surgical suture.There were no patient consequences reported.Additional information was requested.

• Brand Name: GUT CHR UD 8X18IN 1 S/A CT-1 CR
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12349331
• Report Number: 2210968-2021-07562
• Device Sequence Number: 1180415
• Product Code: GAL
• UDI-Device Identifier: 10705031024144
• UDI-Public: 10705031024144
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2021

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: 08/31/2024
• Device Model Number: CC40G
• Device Catalogue Number: CC40G
• Device Lot Number: PQB306
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 77