MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. AUXILIARY WATER TUBE

Model Number MAJ-855

Device Problem Residue After Decontamination (2325)

Patient Problems Abdominal Pain (1685); Ulcer (2274); Chemical Exposure (2570); Gastrointestinal Hemorrhage (4476); Swelling/ Edema (4577)

Event Date 05/30/2023

Event Type  Injury  

Manufacturer Narrative

E1 establishment name: (b)(6).The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Issn:1943-8141/ajtr0146602 a supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

Olympus reviewed the following literature titled "three case reports of glutaraldehyde-induced chemical colitis." currently, chemical colitis in clinical practice is mainly caused by iatrogenic factors.The disinfectant glutaraldehyde is one of the common drugs that can cause chemical colitis, but there are few reports about it.From august 2019 to august 2022, 1457 cases of colonoscopy were performed in the endoscopy room of the second affiliated hospital of zhejiang university school of medicine and songyang county people¿s hospital, and 3 cases of chemical colitis caused by glutaraldehyde residue are discussed in this report.All 3 cases occurred on the same endoscopic system and same day.These 3 patients were hospitalized and treated with bowel rest, hydration, peroral kangfuxin solution, dexamethasone combined with kangfuxin solution local enema treatment, and empiric antibiotic.In conclusion, standardized management of cleaning and disinfection should be strengthened in departments carrying out enteroscopy, especially those using the concentrated glutaraldehyde immersion solution and cleaning after immersion, to prevent the occurrence of acute chemical enteritis related to disinfectant.Patient 1: a 62-year-old male patient underwent an endoscopic mucosal resection (emr) for colonic polyps.After 38 hours of emr, the patient presented with bloody stools, tenesmus without fever, and abdominal pain.The emergency colonoscopy showed that the sigmoid colon and rectal mucosa were extensively hyperaemic with erosive bleeding.Bloody fluid was seen in the intestinal lumen.The wound from emr was intact.The titanium clip was in position.Patient 2: a 36-year-old male patient underwent a total colonoscopy that was unremarkable.Four hours after the procedure, he began to suffer periumbilical abdominal pain for four hours and fever developed 28 hours after the process.Leucocytosis (11,100/ml) was elevated.Computed tomography of the abdomen showed extensive edema and thickening with infiltration from the transverse to the descending colon.The emergency colonoscopy showed extensive hyperemia and edema of the transverse colon with multiple superficial ulcers.Patient 3: this 60-year-old female patient underwent a colonoscopy for tumors screening.Paroxysmal abdominal pain with hematochezia appeared 28 hours after the colonoscopy.Physical examination revealed abdominal tenderness and suspicious rebound pain, with active bowel sounds.An emergency colonoscopy showed multiple deep ulcerations with bleeding.Leukocytosis (18,100/ml) with elevated crp (52.0 mg/ml) was noted.It showed extensive edema and thickening with infiltration from the liver area to the transverse colon.Type of adverse events/number of patients: abdominal pain (all 3 patients), bloody stool (all 3 patients), hyperemia (patient 1 and patient 2), ulceration (patient 2 and patient 3) , chemical exposure (all 3 patients), swelling/edema (patient 2 and patient 3), leukocytosis (patient 2 and patient 3).Type of malfunction: glutaraldehyde residue was detected in the auxiliary channel water tube after decontamination in which the endoscope system was connected (all 3 patients) this literature article requires 6 reports.The related patient identifiers are as follows: (b)(6) (maj-855) patient 1, (b)(6) (cf-h290l) patient 1, (b)(6) (maj-855) patient 2, (b)(6) (cf-h290l) patient 2, (b)(6) (cf-h290l) patient 3, (b)(6) (maj-855) patient 3.This medwatch report is for patient identifier (b)(6).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide additional information received from the author.The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse events cannot be confirmed.There is no evidence of an olympus device malfunction.In addition, the malfunction of the device has not been reported, and from clinical/medical evaluation and risk assessment, it is possible that the reported event is an accident, or a complication associated with a procedure using the subject device.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

Event Description

Additional information received from the author confirms no device malfunction or adverse event occurred when using olympus devices.

• Brand Name: AUXILIARY WATER TUBE
• Type of Device: AUXILIARY WATER TUBE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17332996
• MDR Text Key: 319562848
• Report Number: 9610595-2023-10186
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170071508
• UDI-Public: 04953170071508
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-855
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2023
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: CF-H290L, MAJ1806.
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female