MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO CLOSE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	173022
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	04/01/2019
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, when using the device, the tip of the needle disengaged.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of four devices.The visual inspection of the returned product noted that the devices were completely disassembled.A review of the device history record indicates this product was released meeting all 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.A definitive root cause could not be determined with regard to the reported condition.Without the physical product fully assembled, a definitive root cause could not be identified.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, pre-operatively, when using the device, the tip of the needle disengaged, but it did not fall into the patient's cavity.A new device was used.No injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, pre-operatively, when using the device, the tip of the needle disengaged, but it did not fall into the patient's cavity.A new device was used.No injury.

• Brand Name: ENDO CLOSE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8601530
• Report Number: 2647580-2019-02490
• Device Sequence Number: 2180832
• Product Code: GCJ
• UDI-Device Identifier: 20884521051499
• UDI-Public: 20884521051499
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K954853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2019

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: 05/31/2022
• Device Model Number: 173022
• Device Catalogue Number: 173022
• Device Lot Number: P7E0432X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 05/16/2019; 08/19/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 06/10/2019; 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1