MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL SILS STITCH SUTURING DEVICE; DISPOSABLE SUTURING DEVICE

Catalog Number SILSTITCH

Device Problems Component Falling (1105); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2014

Event Type  malfunction  

Event Description

Procedure: lap nissen.According to the reporter: the instrument didn't grip the needle properly, as the one leg of the instrument remained extended.When he tried to switch the needle, the needle fell out of the jaws.The suture needle stayed within the issue of the pt.The doctor used a grasper to remove the needle from the tissue.As a result of the incident, the procedure time was extended by 10 minutes but there was no blood loss.The doctor loaded the instrument himself to prevent misuse of the instrument.This complaint is related to (b)(4).

Manufacturer Narrative

Tracking number (b)(4).

Manufacturer Narrative

(b)(4).Follow up report sent to fda on 12/24/2014.

Manufacturer Narrative

(b)(4).Follow up report sent to fda on 01/23/2015.

• Brand Name: SILS STITCH SUTURING DEVICE
• Type of Device: DISPOSABLE SUTURING DEVICE
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL; 60 middletown avenue; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL; 60 middletown avenue; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3958637
• MDR Text Key: 4609445
• Report Number: 1219930-2014-00372
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K090419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: SILSTITCH
• Device Lot Number: N3F0424X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 42