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

Model Number 173024

Device Problems Component or Accessory Incompatibility (2897); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 02/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during laparoscopic procedure of jejunostomy, the device was difficult to toggle, load and unload.It w as noted the patient had abdominal wall injury.Seven sutures was done by the surgeon to repair the tear.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The needle was inspected under microscope where one indent (consistent with blade of suturing device) was observed near the 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.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.A definitive root cause could not be determined with regard to the reported condition.However, probable causes could be attributed to premature toggling of suturing device with single use loading unit(sulu).The indent observed may occur when pressure is applied on the toggle lever of the suturing device prior to closing the handles and prematurely attempting to toggle.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGIDAC
• 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: 8391188
• MDR Text Key: 137850715
• Report Number: 9612501-2019-00423
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10884521129450
• UDI-Public: 10884521129450
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173024
• Device Catalogue Number: 173024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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