MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT SINGLE USE DISTAL COVER

Model Number	MAJ-2315
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Date of Event	03/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to an olympus endoscopy account manager that a patient had an endoscopic retrograde cholangiopancreatography (ercp) using an evis exera iii duodenovideoscope (tjf-q190v) with disposable cap (subject device, maj-2315).Suction was set at 120mm/hg for this procedure.During this procedure, the doctor noticed bleeding from the patient's mouth after the scope was inserted.The doctor withdrew the tjf-q190v scope, and the procedure was aborted.The patient had to remain intubated after the procedure.The patient was transferred to another hospital for a higher level of care.Five days later, a repeat ercp and esophagogastroduodenoscopy (egd) was performed by a second doctor using the older model scope without disposable tip.During this procedure the doctor saw a 13cm long 2-3mm wide healing laceration extending from her ge junction to the upper mid esophagus.The injury necessitated blood transfusion, prolonged endotracheal intubation following the initial ercp, hospital transfer to a higher level of care, several more days stay as an inpatient, as well as causing significant painful swallowing for 2-3 days.The patient's current condition was described as recovered fully, discharged home, with a planned ercp to remove the bile duct stent which was placed, probably in mid to late (b)(6) 2021.Additional information was later provided by the customer: the customer was unaware of the scope ¿malfunctioning.¿ the disposable cap used in the procedure was not available for evaluation, it was discarded after the procedure.Operative reports were provided with the following information: for the procedure completed (b)(6) 2021: the patient took enoxaparin last one day prior to the procedure.The patient's asa (anesthesia risk score) was iii-patient with severe systemic disease.The diagnostic ercp was aborted due to pyloric stenosis and esophageal mucosal injury resulting from the passage of the duodenoscope with bleeding.The ercp was technically difficult and complex due to excessive bleeding and duodenal stenosis.Evaluation of the duodenoscope revealed the plastic tip in proper position.For the procedure completed (b)(6) 2021: the patient's asa (anesthesia risk score) was iii-patient with severe systemic disease.The patient's pylorus was slightly strictured and required dilation before passing the tjf-180 scope without distal cap.Multiple attempts (over a 30 min period) were required to cannulate the bile duct.A bile leak was visualized at the level of the cystic duct clips.A stent was placed in good position.No further consequences to the patient have been reported.This report is for the maj-2315 (single use distal cover).This report is related to complaint number (b)(4), which was reported for the tjf-q190v scope under mdr number 8010047-2021-04836.This event has been submitted by the importer on mdr number 2429304-2023-00021.
Additional Manufacturer Narrative
The device history record was not able to be reviewed for this device (maj-2315) since the lot number was not provided, and the device was not returned for evaluation.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.A review was performed on the manufacturing process to determine if there has been any change on 5m which could affect the product.There was no abnormality or deviation that could contribute to the reported issue.In addition, the manufacturer tested a distal cover in their stock and verified that it conforms to the product specification.Based on the results of the legal manufacturer's investigation, although a definitive root cause could not be determined, the following are presumed to be the likely causes: if suction is activated or the distal end of the scope is pushed against the mucous while removing the scope, gap(space) can develop between forceps elevator and forceps channel, and between forceps elevator and the distal cover.Mucous can be trapped in the gap and damaged by the edge of the distal cover.It could lead to tissue injury, and tissue being embedded in the distal cover.It has been found from the corrective and preventative (capa) action investigation that the mucous membrane is maintained in the sucked state for several seconds even after the suction operation is stopped, and the suction operation is not performed during the removal.Even if the tip cover is not cracked, mucosal damage can occur if the scope is removed immediately after the suction operation is stopped.The instructions for use (ifu) provides the user the following information related to the reported event: "important information ¿ please read before use: examples of inappropriate handling: applying suction with the distal end of the endoscope in prolonged contact with the mucosal surface, with higher suction pressure than required, or with prolonged suction time may cause bleeding and/or lesions.3.5 attaching accessories to the endoscope: attaching the single use distal cover: never use a single use distal cover with cracks or pinholes.Replace it with a new one.If a single use distal cover with cracks or pinholes is used, it could fall off during the examination and/or, it may cause thermal injury due to electric current leaks from cracks or pinholes when high-frequency cauterization treatment is performed.Also, using the single use distal cover with cracks may cause patient injury due to sharp edges." investigation activities have been opened to manage the actions related to this report and any required mdr reporting.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE DISTAL COVER
• Common Device Name: DISTAL COVER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0 182; JA 190-0182
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0 182; JA 190-0182
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16345559
• Report Number: 3003637092-2023-00056
• Device Sequence Number: 6729413
• Product Code: FDT
• UDI-Device Identifier: 04953170403019
• UDI-Public: 04953170403019
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K220587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/10/2023

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
• Operator of Device: Health Professional
• Device Model Number: MAJ-2315
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1292-2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS GIF-H190 S/N (B)(4).; OLYMPUS TJF-Q190V S/N (B)(4).
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Race: White