MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON ENDO STITCH* POLYSORB* 3/0 7 U/D DLU SU; SINGLE USE SUTURING DEVICE

Model Number 170072

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/28/2015

Event Type  malfunction  

Event Description

Procedure type : laparoscopic hysterectomy.According to the reporter: first device: needle broke off from both strand and the jaw when trying to pass through vaginal cuff tissue.Half of needle remained in jaws, the other half was no recovered, patient was x-rayed, needle was unable to be located.Second device was with polysorb reload, worked fine on tissue but when unloaded on mayo stand, needle was broken in two pieces.In both instances, sulu was loaded correctly, rabbit ears were fully retracted, needle was passed back and forth before being inserted through trocar.The current patient status is unknown.There was no tissue loss or damage.The case was delayed by an hour to search for the needle and x-ray the patient.The vaginal cuff was closed from below.

Manufacturer Narrative

(b)(4).

• Type of Device: SINGLE USE SUTURING DEVICE
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4823978
• MDR Text Key: 19006792
• Report Number: 1219930-2015-00454
• Device Sequence Number: 1
• Product Code: GDW
• 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: Initial,Followup
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: 170072
• Device Catalogue Number: 170072
• Device Lot Number: B3H0525X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1