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

Model Number 170053

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, pre-operatively, it was discovered that there was no needle on the suture.The customer claimed it did not come with a needle at all.There was no patient involvement.

• Brand Name: POLYSORB
• 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: 8652568
• MDR Text Key: 146481947
• Report Number: 9612501-2019-01045
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 20884521126739
• UDI-Public: 20884521126739
• 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: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 170053
• Device Catalogue Number: 170053
• Device Lot Number: J8E0087X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2019
• Date Device Manufactured: 05/01/2018
• 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