MAUDE Adverse Event Report: COVIDIEN ENDO STITCH* 10MM SUTURING DEVICE; SINGLE USE SUTURING DEVICE

Model Number 173016

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104); Device Embedded In Tissue or Plaque (3165)

Event Date 08/05/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Procedure: total lap hysterectomy.According to the reporter: the needle broke off in patient during the procedure.An xray was done but the needle could not be seen on the xray.Needle was left in the patient.Patient was admitted to the hospital.There was no unanticipated tissue loss.The incision was not extended by more than one inch.There was no unanticipated blood loss of 500cc or more.Surgery time was delayed by more than 30 minutes.The device will be returned for evaluation.Yes.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Post marketing vigilance led an evaluation of two devices and one label of a reload opened by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, pmv review of complaint trends, an engineering evaluation, and an evaluation of the returned device.A pmv needle was loaded onto the subject instrument.The needle was found to function properly when applied through layers of test media.Pressure was exerted on the needle in all directions and from both sides of the jaw to simulate clinical conditions.The needle was loaded and unloaded without difficulty.No difficulty was experienced in loading, unloading, or toggling the needle.Engineering confirmed the apmv findings.Visual and functional testing of the returned sample confirmed the product met quality release specifications that were tested regarding the reported conditions.A review of the device history record indicates this device lot number was released meeting all medtronic quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened.

• Type of Device: SINGLE USE SUTURING DEVICE
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: sharon murphy ; north haven; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5008003
• MDR Text Key: 23189351
• Report Number: 9612501-2015-00475
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J5B1456X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 112