MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE

Model Number URF-V

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

Patient Problem Pulmonary Edema (2020)

Event Type  Injury  

Event Description

Olympus medical systems corp.(omsc) received a literature titled "effects of irrigation fluid temperature during flexible ureteroscopic holmium laser lithotripsy on postoperative fever and shivering: a randomized controlled trial".The literature reported the result of 120 patients with urinary tract calculi who underwent flexible ureteroscopic holmium laser lithotripsy procedure using olympus urf-v and another device.In the literature, the following complications have been reported to have occurred.Fever (25 cases).Suspected infection (10 cases).Flash pulmonary edema (1 case).Postoperative hemorrhage (1 case).Urinary retention (1 case).Ureteral abrasion (1 case).The literature states as follows, "primary and secondary outcomes the incidence of postoperative fever (core body temperature>37.5 during the 48 h after surgery) differed significantly between 37 group (5/37, 13.5%), 27 group (6/35, 17.1%) and 17 group (14/36, 38.9%) (p<0.05 for all pairwise comparisons; table 2).Similarly, the incidence of postoperative shivering differed significantly between 37 group (1/37, 2.7%), 27 group (2/35, 5.7%) and 17 group (8/36, 22.2%) (p<0.05 for all pairwise comparisons; table 2).Postoperatively there were no significant differences between groups in the incidence of suspected infection (core body temperature>38.5¿ and pct>0.5 ¿g/l), wbc count, pct level or creatinine level, duration of hospital stays (table 2).Other complications there was one case of flash pulmonary edema (the patient recovered and was discharged after medical therapy) and one case of postoperative hemorrhage (which stopped 3 days after placement of a three-cavity catheter for bladder irrigation) in 37 group.There was one case of urinary retention (the catheter was successfully removed after 1 week) in 37 group and one case of ureteral abrasion (the ureteral stent was removed two months later) in 17 °c group.There were no adverse events above grade iii (clavien-dindo grading system) in this study." there are not mentioned that these complications were related to the subject device in question.Based on the available information, specific information on the subject device and the patients were not provided.There is no description of the device's malfunction.However, omsc assumes that "flash pulmonary edema" might be related to the subject device, and the subject device might be caused or contributed to a death or serious injury because the literature stated that "the patient recovered and was discharged after medical therapy," suggesting that the hospitalization was prolonged.Also, omsc determined that other complications are not serious events based on the descriptions in the literature.Therefore, omsc determined that the "flash pulmonary edema" was adverse event to submit.Omsc will submit a medical device report (mdr) depending on the event.

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the serial number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there is no description of the device's malfunction.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13186603
• MDR Text Key: 288659557
• Report Number: 8010047-2022-01030
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2022

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?: No
• Device Model Number: URF-V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization