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

Model Number	CL-270
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2018
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 esophagus procedure, when the doctor opened the package, he noticed that the thread was white and broke into pieces.Hydrolysis was proceeding.They then used another device to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted fragments of sutures.There was no sealed products were returned.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: POLYSORB
• 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: 7413559
• Report Number: 9612501-2018-00717
• Device Sequence Number: 1236013
• Product Code: GAM
• UDI-Device Identifier: 10884521040427
• UDI-Public: 10884521040427
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

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: 06/30/2019
• Device Model Number: CL-270
• Device Catalogue Number: CL-270
• Device Lot Number: D4F1336X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Initial Date Received by Manufacturer: 03/23/2018
• Supplement Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1