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

Model Number	VP-703-X
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	05/16/2018
Type of Reportable Event	Malfunction
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 an anastomosis, the needle broke and the surgical time was extended for thirty minutes or more due to the product problem.New sutures had to be used.There was no patient injury.
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an anastomosis, the needle detached from the strand and the surgical time extended for thirty minutes or more due to the product problem.New sutures had to be used.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) received one device.A tactile and microscopic inspection of the sutures was performed with no abnormalities.The visual inspection of the opened sample noted no sutures and one needle.The needle was returned disengaged from the suture.Under microscopic inspection, instrument marks were noted near the swaged end of the needle.A needle attachment test was performed on the sealed samples, and the results met the specifications for this product.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 root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.Grasping the needle at the swaged end can cause the needle to break, bend, or become disengaged from the suture.The needle should always be grasped in the middle, where the diameter is greatest.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGIPRO LL
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7537516
• Report Number: 9612501-2018-01041
• Device Sequence Number: 19307454
• Product Code: GAW
• UDI-Device Identifier: 20884521038186
• UDI-Public: 20884521038186
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K050947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: VP-703-X
• Device Catalogue Number: VP-703-X
• Device Lot Number: D7C1003PX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 08/10/2018; 09/04/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 08/28/2018; 09/26/2018
• 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: Other