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

Model Number	170057
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, intra-operatively in a roux-en-y gastrojejunostomy/ gastric bypass, the device needle broke off and fell into the patients cavity, it was retrieved using a laparoscopic grasper.A new endostitch needle was opened and loaded on the same device to resolved the issue and complete the case.The patient was alive with no injury.The device is not expected to be returned for evaluation.

• Brand Name: POLYSORB
• 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: 6787108
• Report Number: 9612501-2017-05933
• Device Sequence Number: 1566437
• Product Code: KOG
• UDI-Device Identifier: 20884521126593
• UDI-Public: 20884521126593
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2017

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: 03/31/2021
• Device Model Number: 170057
• Device Catalogue Number: 170057
• Device Lot Number: J6C2016X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 08/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1