MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIPRO LL; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number VP-705-X

Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 05/24/2018

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 the procedure, the needle broke.They told for 2 years we have been in dialogue with the supplier about problems with broken and bent needles and threads that also break.They have received 5 unintended events with needles that have broken during a surgery.The pouring date is just an example of date as there have been many events.They always try to find tips that are broken, but because of the very small metal pieces that are hardly visible, there may be instances where microscopic metal pieces are left in the patient.

Manufacturer Narrative

Correction: supplemental report created to correct previously sent information.The event date is not available and was sent in error in the initial report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGIPRO LL
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 8155285
• MDR Text Key: 130056588
• Report Number: 9612501-2018-02213
• Device Sequence Number: 1
• Product Code: GAW
• UDI-Device Identifier: 20884521038230
• UDI-Public: 20884521038230
• Combination Product (y/n): N
• PMA/PMN Number: K050947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: VP-705-X
• Device Catalogue Number: VP-705-X
• Device Lot Number: D5G2184X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 03/12/2019
• Supplement Dates FDA Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other