MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS OLYMPUS GLIDEWIRE 150 CM; GUIDEWIRE

Lot Number 1802020

Device Problem Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/11/2019

Event Type  Injury  

Event Description

(b)(6) year old female with a history of right flank pain due to right ureteropelvic junction obstruction.Pt scheduled for elective robotic right pyeloplasty secondary to right ureteropelvic junction obstruction.Prior to the end of the surgical case, a fluoroscopic guidance kub was completed.Two static images of the abdomen / pelvis were archived at the end of the procedure prior to the pt leaving the operating room.The pt's intra-op static images showed a "thin, short, linear density projected over the right lower quadrant of the abdomen" and could not rule out the possibility of a foreign body.For pt safety purposes, images were submitted for radiologist review and evaluated for unexpected findings.The surgeon was notified of results and ordered a repeat kub which showed a "foreign body in the pt's lower quadrant on the right side." the surgeon ordered a ct scan without contrast that confirmed the presence of a foreign body adjacent to the colon on the right side.The findings were relayed to surgeon as a critical finding.The pt returned to surgery on (b)(6) 2019 at 1701 for a laparoscopy and removal of the foreign body.Fda safety report id# (b)(4).

• Brand Name: OLYMPUS GLIDEWIRE 150 CM
• Type of Device: GUIDEWIRE
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS ; southborough MA
• MDR Report Key: 9150986
• MDR Text Key: 161306733
• Report Number: MW5090191
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Lot Number: 1802020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 10 YR
• Patient Weight: 34