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

Model Number MAJ-2315

Device Problem Material Twisted/Bent (2981)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 01/26/2022

Event Type  Injury  

Event Description

The customer reports, during a decompression endoscopic retrograde cholangiopancreatography (ercp) using an evis exera iii duodenovideoscope with a single use distal cover, and an unspecified esophagogastroduodenoscopy (egd) scope, (there were no issue with the egd scope) the physician saw a lot of bleeding during the procedure and upon removal of the scope, the distal cover was twisted leaving the metal ridge on the distal tip of the scope exposed.There were anatomical challenges encountered during the procedure.The patient's anatomy was described as: extremely j-shaped stomach with the entrance to the pylorus at an unusual angle the bleeding was found to be caused by a 12mm in length laceration to the muscularis found on the greater curvature of the stomach.The physician stopped the bleeding using hemostasis clips and was able to complete the procedure.There was no abnormality in the appearance of the scope or distal cover prior to the initiation of the procedure.The distal cover used in the procedure was discarded and cannot be returned for evaluation.No images an be provided.The patient's current condition is deceased, not related to the laceration, but due to underlying pathology.Case with patient identifier (b)(6) reports the evis exera iii duodenovideoscope used in the procedure.Case with patient identifier (b)(6) reports the single use distal cover used in the procedure.

• Brand Name: SINGLE USE DISTAL COVER
• Type of Device: DISTAL COVER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 13588932
• MDR Text Key: 286044560
• Report Number: 2951238-2022-00322
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/27/2022,02/23/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-2315
• Device Lot Number: H1203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/27/2022
• Date Report to Manufacturer: 01/27/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TJF-Q190V SN(B)(4), EGD SCOPE
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 55 KG