MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number UNK_OARM_SYS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fistula (1862)

Event Date 06/20/2014

Event Type  Injury  

Manufacturer Narrative

Patient age is average age of patients in the study.Patient gender is denoted as male however article indicates that gender of the patients in the study were half male/half female.Patient weight was not included in the journal article.Please note that this date is based off of the date the article was published as the event dates were not provided in the published literature.Article citation is included.System product number and serial number not provided in journal article.Udi not available for this system.No 510k provided as system is unknown.No evaluation was performed as this event was reported in literature.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: ohtaka, k., takahashi, y., kaga, k. et al. video-assisted thoracoscopic surgery using mobile computed tomography: new method for locating of small lung nodules. j cardiothorac surg 9, 110 (2014).Https://doi.Org/10.1186/1749-8090-9-110.Abstract: background: the o-arm is an intraoperative imaging device that can provide computed tomography images.Surgery for small lung tumors was performed based on intraoperative computed tomography images obtained using the o-arm.This study evaluated the usefulness of the o-arm in thoracic surgery.Methods: from july 2013 to november 2013, 10 patients with small lung nodules or ground glass nodules underwent video-assisted thoracoscopic surgery using the o-arm.A needle was placed on the visceral pleura near the nodules.After the lung was re-expanded, intraoperative computed tomography was performed using the o-arm.Then, the positional relationship between the needle marking and the tumor was recognized based on the intraoperative computed tomography images, and lung resection was performed.Results: in 9 patients, the tumor could be seen on intraoperative computed tomography images using the o-arm.In 1 patient with a ground glass nodule, the lesion could not be seen, but its location could be inferred by comparison between preoperative and intraoperative computed tomography images.In only 1 patient with a ground glass nodule, a pathological complete resection was not performed.There were no complications related to the use of the o-arm.Conclusions: the o-arm may be an additional tool to facilitate intraoperative localization and surgical resection of non-palpable lung lesions.Reported events: in one patient with a ground glass nodule (ggn) tumor, a pathological complete resection was not able to be achieved.It was noted that this may have been caused by a technical error during resection.This patient underwent additional resection later.Three of the ten patients had a postoperative pulmonary fistula.

• Brand Name: O-ARM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9943439
• MDR Text Key: 188827689
• Report Number: 3004785967-2020-00455
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK_OARM_SYS
• Device Catalogue Number: UNK_OARM_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR