MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD CHROMIC GUT; SUTURE, ABSORBABLE, NATURAL

Model Number	GG-123
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, while using an interrupted v-20 needle suturing technique in an open hysterectomy procedure, the needle broke during closing.They had to open an additional gut suture to close and resolve the issue.There was no patient injury.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of one image of a device.The needle appeared to have something hanging off the tip.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: CHROMIC GUT
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 6903888
• Report Number: 9612501-2017-06302
• Device Sequence Number: 483130
• Product Code: GAL
• UDI-Device Identifier: 20884521054902
• UDI-Public: 20884521054902
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K885018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2018

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: 11/30/2019
• Device Model Number: GG-123
• Device Catalogue Number: GG-123
• Device Lot Number: D6L2140ZX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 09/29/2017
• Supplement Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1