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

Model Number 170040

Device Problems Detachment of Device or Device Component (2907); Human-Device Interface Problem (2949); Material Twisted/Bent (2981)

Patient Problem No Information (3190)

Event Date 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.Visual and microscopic inspection of the returned needles noted that there were no abnormalities.The returned needles were found to function properly and remained engaged in the test instrument throughout testing.No difficulty was experienced in loading, unloading or toggling the returned needles.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.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, while being applied on closure of the crura during laparoscopic hiatal hernia, the needle broke off the suture, and another needle and suture snapped off.It was reported that the device was difficult to toggle, and another device bent the needle inside it.However, the needle was retrieved by using graspers.Another device was used to complete the case.

• 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: 9416058
• MDR Text Key: 169265846
• Report Number: 9612501-2019-02325
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 20884521126999
• UDI-Public: 20884521126999
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 170040
• Device Catalogue Number: 170040
• Device Lot Number: J7L1503X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2017
• 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