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

Model Number	170051
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: health professional (hpro).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, when the device was being applied to the jejunum during the sewing of the gastrojejunostomy on a laparoscopic roux en y gastric bypass, the device was difficult to unload at one point.The needle disengaged completely from the device but was still in the small bowel with the strand of suture attached, so it was visible the entire time.A new reload was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of a foil packaging and retainers of one device.Only foil packages and retainers were returned.Visual inspection found no abnormalities that would have caused or contributed to the reported condition.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all medtronic quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: POLYSORB
• 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: 7712521
• Report Number: 9612501-2018-01338
• Device Sequence Number: 1107938
• Product Code: OCW
• UDI-Device Identifier: 20884521126753
• UDI-Public: 20884521126753
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K934738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2018

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: 10/31/2022
• Device Model Number: 170051
• Device Catalogue Number: 170051
• Device Lot Number: J7K1861X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 10/12/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 10/03/2018; 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1