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

Model Number 21-345

Device Problems Component Missing (2306); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a diagnostic bronchoscopy, thoracoscopy, when cleaning the trocar port, the trocar wipe came off t he cleaner stick and fell into the thoracic cavity.The doctor retrieved the missing sponge cleaner tip.The tip was matched to the end of the cleaner stick.No other pieces were missing.The port cleaner and box was bagged and given to the manager.It appeared the foam tip of the wipe was torn off.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLEARIFY
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7751917
• MDR Text Key: 116389370
• Report Number: 2647580-2018-03902
• Device Sequence Number: 0
• Product Code: GCJ
• Reporter Country Code: US
• PMA/PMN Number: K062779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: 21-345
• Device Catalogue Number: 21-345
• Device Lot Number: P8B1470HX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/20/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/04/2018
• Date Device Manufactured: 02/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Age: 36 YR