MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 27IN 3-0 S/A RB-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y305H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported that a patient underwent a total cystectomy procedure on an unknown date and suture was used.The needle detached from the suture during continuous suturing.It was not a control release needle.Further details were not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: it was received for analysis a labeled winding former with a undispensed suture piece, a detached needle and suture piece of product code y305.During the visual inspection of the detached needle, marks at the body of the needles and no remnant at the barrel hole could be observed.The sutures piece were observed cut appears to be by use of a surgical instrument and a end a correct insertion mark was observed.However, the force used to detach needle from the suture could not be determined.The manufacturing records could not be reviewed as the batch number is unknown per the condition of the sample, it could not be determined what may have caused the reported incident of: ¿2 needles (y305h and sxpp1a300) were detached from the sutures¿.Device sxpp1a300 captured in mw report 2210968-2019-87667.

• Brand Name: MCRYL VIO 27IN 3-0 S/A RB-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 9076323
• Report Number: 2210968-2019-87669
• Device Sequence Number: 19445963
• Product Code: GAN
• UDI-Device Identifier: 10705031058712
• UDI-Public: 10705031058712
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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: Y305H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 10/30/2019
• Patient Sequence Number: 1