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

Model Number MAJ-2315

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Pain (1994); Unspecified Tissue Injury (4559)

Event Date 05/09/2021

Event Type  Injury  

Event Description

Olympus medical systems corp.(omsc) was informed during an endoscopic retrograde cholangiopancreatography (ercp) tissue was found inside the distal cap of the single use distal cover immediately after the procedure.The physician stated that he followed the olympus recommendation to avoid suctioning when withdrawing the scope.An upper endoscopy was performed immediately after completing the ercp as the tissue was noted immediately after the procedure.There was trauma to the stomach (fresh blood and clot) in the proximal corpus along the lesser curvature.Endoscopic hemostasis wasn't required.The patient did have pain after the procedure, though this is likely pain from her recent incisions related to her gallbladder surgery and drain.The patient was treated with a proton pump inhibitor to heal the erosions and scope trauma.This is related to patient identifier (b)(6) which was reported under mfr report number 8010047-2021-06827 and importer report number 2951238-2021-00339.

• Brand Name: SINGLE USE DISTAL COVER
• Type of Device: 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
• MDR Report Key: 16342480
• MDR Text Key: 309264530
• Report Number: 2429304-2023-00019
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170403019
• UDI-Public: 04953170403019
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2021,02/09/2023

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
• Device Operator: Health Professional
• Device Model Number: MAJ-2315
• Device Lot Number: H9510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/10/2021
• Date Report to Manufacturer: 05/10/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TJF-Q190V: SN (B)(4).
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 73 KG