MAUDE Adverse Event Report: US SURGICAL PUERTO RICO EEA; STAPLE, IMPLANTABLE

Model Number	EEAXL2135
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2019
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 total gastrectomy, when the product was taken out of the blister pack to be used in combination with the orvil, when the twit knob was slued, it came off.The connection part was disconnected, so the doctor tried to push the knob (which came off) once more into the projection of the handle, and it seemed that the product was able to be used without problems but the doctor felt uncomfortable and had a concern, so the reported product was stopped using, and a new product was opened.The surgical time was extended by less than 30 minutes.There was no patient injury.

• Brand Name: EEA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8560092
• Report Number: 2647580-2019-02294
• Device Sequence Number: 2192006
• Product Code: GDW
• UDI-Device Identifier: 20884523005582
• UDI-Public: 20884523005582
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/29/2019

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: 12/31/2023
• Device Model Number: EEAXL2135
• Device Catalogue Number: EEAXL2135
• Device Lot Number: P9A1294KY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1