MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SILS STITCH; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	SILSSTITCH
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).(b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic total hysterectomy, on vaginal cuff closure, the needle kept breaking, which added at least an hour to the patient¿s surgery.The needle fell into the patient¿s cavity.It was retrieved via a laparoscopic grasping device but extended the case significantly and the surgeon ended up closing the vaginal cuff via hand stitch through the vaginal vault to complete the case.The procedure was converted to open due to the device problem.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.Device two was returned loaded with a broken needle in the left jaw of the device.Device two had bent blades.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the bent blade indicates that the instrument may have been exposed to an external force which bent the exposed metal bars.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SILS STITCH
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7731144
• Report Number: 1219930-2018-04131
• Device Sequence Number: 1365672
• Product Code: OCW
• UDI-Device Identifier: 20884521100029
• UDI-Public: 20884521100029
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K090419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: SILSSTITCH
• Device Catalogue Number: SILSSTITCH
• Device Lot Number: N6J0989X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 10/11/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 10/03/2018; 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention