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

Model Number	170004
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191)
Date of Event	03/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7451204
• Report Number: 9612501-2018-00818
• Device Sequence Number: 13796147
• Product Code: OCW
• UDI-Device Identifier: 10884521126909
• UDI-Public: 10884521126909
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K934738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2018

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: 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
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 07/05/2018
• 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