MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO RETRACT; RETRACTOR

Model Number	176613
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a radical prostatectomy procedure, at the beginning of the surgical procedure, a piece of device was lost inside patient's intraoperative space.The operator saw it and removed it from the abdomen.There was no patient injury.

• Brand Name: ENDO RETRACT
• Common Device Name: RETRACTOR
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 7073499
• Report Number: 2647580-2017-08081
• Device Sequence Number: 1119053
• Product Code: GAD
• UDI-Device Identifier: 10884523000849
• UDI-Public: 10884523000849
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K914190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2017

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: 09/30/2021
• Device Model Number: 176613
• Device Catalogue Number: 176613
• Device Lot Number: P6J0836X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 80