MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD BRALON; ENDOSCOPE AND/OR ACCESSORIES

Model Number	170012
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during the laparoscopic roux-en-y procedure the needle on the reload fell of the jaws and disengaged into the patient.To complete the procedure, the physician used graspers and retrieved the needle, a new reload was pulled and used without issue.There was no harm caused to the patient.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: BRALON
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 6515279
• Report Number: 9612501-2017-05382
• Device Sequence Number: 19053691
• Product Code: KOG
• UDI-Device Identifier: 10884521126978
• UDI-Public: 10884521126978
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/18/2017

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: 10/31/2021
• Device Model Number: 170012
• Device Catalogue Number: 170012
• Device Lot Number: J6K1238X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2017
• Supplement Date Received by Manufacturer: 04/18/2017
• Initial Report FDA Received Date: 04/24/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 111