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

Model Number	VP-585-X
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title: clinical trial of pancreaticogastrostomy versus pancreaticojejunostomy regarding incidence of delayed gastric emptying after pancreaticoduodenectomy source: langenbeck's archives of surgery (2020) 405:921¿928.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the literature source, a prospective study compared pancreaticogastrostomy (pg) and pancreaticojejunostomy (pj) with regard to the incidence of delayed gastric emptying in patients who underwent pancreaticoduodenectomy between may 2013 and january 2016.There were 27 pg patients and 26 pj patients.The device was used for the pancreaticogastrostomy.Complications included: blood loss greater than 500ml, abdominal abscess, and intra-abdominal hemorrhage.

• 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 ; DR 0101
• MDR Report Key: 11706007
• Report Number: 9612501-2021-00649
• Device Sequence Number: 3946479
• Product Code: GAW
• UDI-Device Identifier: 10884521038004
• UDI-Public: 10884521038004
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2021

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
• Operator of Device: Health Professional
• Device Model Number: VP-585-X
• Device Catalogue Number: VP-585-X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 04/22/2021
• 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: Required Intervention