MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD AUTO SUTURE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	24055
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 the procedure, plastic slats broke inside the patient's body.They were able to retrieve the pieces from within the patient.There was no patient injury.

• Brand Name: AUTO SUTURE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7625750
• Report Number: 9612501-2018-01156
• Device Sequence Number: 16492967
• Product Code: GCJ
• UDI-Device Identifier: 10884521080829
• UDI-Public: 10884521080829
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K981941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2018

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: 05/31/2019
• Device Model Number: 24055
• Device Catalogue Number: 24055
• Device Lot Number: J4E0436X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1