MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-XP260

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

Patient Problem Sepsis (2067)

Event Type  Injury  

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.

Event Description

On dec.7, 2021, olympus medical systems corp.(omsc) received the literature titled "experience with a hybrid procedure involving laparoscopic fundoplication with percutaneous endoscopic gastrostomy in chronically ill children".Between march 2012 and november 2019, patients aged under 18 years who underwent lnf and gastrostomy with either lg or peg were recruited at the hospital.Fourteen patients underwent laparoscopic nissen fundoplication (lnf) with laparoscopic gastrostomy (lg) and 49 underwent lnf with percutaneous endoscopic gastrostomy (peg).The median age and body weight of patients were 4.25 years and 14.15 kg in the lg group and 2.58 years and 10.60 kg in the peg group, respectively.Sixty-three patients (33 male and 30 female) underwent lnf with simultaneous gastrostomy.A total of 14 patients (nine male and five female) underwent lg, and 49 patients (24 male and 25 female) underwent peg.For the peg, a endoscope(gif-xp260) was used.In the literature for the procedure, it was reported that the following.Hiatal hernias requiring repair were found in 22 cases.Local inflammation at the gastrostomy site was reported in seven patients in the peg group.One case of peritonitis occurred in the peg group.One patient died of klebsiella pneumoniae sepsis on the sixth postoperative day in the peg group.All other patients with early complications recovered after supportive care.In this study, a (b)(6) old female diagnosed with hypoxic ischemic encephalopathy due to birth asphyxia died during hospitalization for surgery.She had recurrent aspiration pneumonia and her clinical course was uneventful at the time of surgery until the fourth postoperative day.She started feeding on the second postoperative day and passed stools on the third postoperative day.She developed a fever on day five post-operation and was diagnosed with klebsiella pneumoniae sepsis and died the following day.In this case, it was not clear whether the operation was a direct cause of death.The mean follow-up duration was 26.6±16.5 months in the peg groups.During the long-term follow-up, three patients died of complications from an underlying disorder in the peg group.Based on the available information, the reported events (hernias, inflammation, peritonitis, death, early complications) were not reported in a direct relationship with the olympus products.However, omsc assumes that the death from klebsiella pneumoniae sepsis might be related to the subject device since the subject device was used for the procedure.And, omsc assumes that the death from klebsiella pneumoniae sepsis might be caused or contributed to a death or serious injury.Omsc assumes that the hernias and the death(three cases) were not related to the subject device due to the following report, respectively.Table 2.Underlying diseases of patients according to gastrostomy type the mean follow-up duration was 26.6±16.5 months in the peg groups.Three patients died of complications from an underlying disorder.Omsc assumes that the inflammation and the peritonitis were not related to the subject device due to such as the following report on how the device is used.In the peg group, after conventional lnf, endoscopy (gif-xp260) was performed, and peg was performed using the pull-through technique.By using a snare through the endoscope, a thin wire guide needle was captured and pulled out through the mouth.Following the wire, a 20 fr mushroom gastrostomy tube (cook medical) was introduced.Omsc assumes that the early complications were not serious due to the following report.All other patients with early complications recovered after supportive care.Therefore, omsc assumes that the death from klebsiella pneumoniae sepsis was adverse event to submit.Based on the available information, specific information on the subject device and the patient (except for some, for example, age) were not provided.There is no description of the device's malfunction.Omsc will submit one medical device report (mdr) of the subject device for the death from klebsiella pneumoniae sepsis.

• Brand Name: EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL 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: 13049453
• MDR Text Key: 282545097
• Report Number: 8010047-2021-16465
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: GIF-XP260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2021
• 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): Death
• Patient Age: 7 MO
• Patient Sex: Female