MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MAXON; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	8886612421
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	05/25/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during an open whipple procedure, the device was difficult to use.The surgeon stated specifically when pulling the suture through the pancreatic duct, the suture pulled less smoothly and was stickier.The surgeon was able to complete the case with no issue despite this concern that the suture was dragging.No patient injury has been noted.The patient is in the icu with a pancreatic leak attributed to the suture, because of the way it pulls tissue and does not glide as easily.The patient has not had a reoperation.The patient is in the icu and is intubated with having gone through drains.

• Brand Name: MAXON
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 6692647
• Report Number: 9612501-2017-05729
• Device Sequence Number: 1078267
• Product Code: GAM
• UDI-Device Identifier: 20884523002079
• UDI-Public: 20884523002079
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K990951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2017

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 Expiration Date: 10/31/2021
• Device Model Number: 8886612421
• Device Catalogue Number: 8886612421
• Device Lot Number: D6K1395X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2017
• Initial Report FDA Received Date: 07/07/2017
• 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
• Patient Age: 63 YR
• Patient Weight: 97