MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SOFSILK; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number 170004

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 03/14/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during thoraco/ esophagus procedure, while suturing, the needle broke at the center.The surgeon said that the device was used as usual and the tissue was neither too thick nor hard.The part fell into the patient's cavity and was retrieved.The incision site was extended by more than 3 cm and surgical time was extended by more than 30 minutes.Tissue damage was also noted.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Broken needle was returned lodged in right jaw of suturing device; needle was broken at loading slot.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly or component related failures.Replication of the bent or broken needle may occur when the needle is not loaded properly or when the needle is forced into an obstacle.This condition may also occur if excess pressure is exerted on the needle or the attached suture while the jaws are in the open position.In these situations, the needle may flex and ultimately break.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during thoraco/ esophagus procedure, while suturing, the needle broke at the center.The surgeon said that the device was used as usual and the tissue was neither too thick nor hard.The part fell into the patient's cavity and was retrieved.The incision site was extended by more than 3 cm and surgical time was extended by more than 30 minutes.Tissue damage was also noted.The procedure was completed with another device.

• Brand Name: SOFSILK
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7451204
• MDR Text Key: 106182321
• Report Number: 9612501-2018-00818
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10884521126909
• UDI-Public: 10884521126909
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K934738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 170004
• Device Catalogue Number: 170004
• Device Lot Number: J7G2001X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention