MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIDAC; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	170043
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Radiation Exposure, Unintended (3164)
Date of Event	10/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter ,occurred during a laparoscopic thoracotomy procedure.The suturing device was being applied to the chest.The needle broke into two pieces and fell into the cavity of the patient.An x-ray was performed that day.The other half could not be found.There was no additional patient harm.The patient outcome is alive, no injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Only the product label was returned, this showed no abnormalities.A review of the device history record could not be performed because the lot number was not provided.However, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all manufacturer¿s quality release specifications at the time of manufacture.As an inadequate sample was received, a product label without the physical product, a definitive root cause could not be identified.Should new information become available, the file will be re-opened and the investigation will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGIDAC
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7029305
• Report Number: 9612501-2017-06580
• Device Sequence Number: 19219544
• Product Code: OCW
• UDI-Device Identifier: 10884521128972
• UDI-Public: 10884521128972
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K934738
• 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,Followup
• Report Date (Section B): 02/13/2018

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: 05/31/2022
• Device Model Number: 170043
• Device Catalogue Number: 170043
• Device Lot Number: J7E1197X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 02/13/2018
• 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; Required Intervention