MAUDE Adverse Event Report: OLYMPUS AMERICA, INC SINGLE USE DISTAL COVER; ENDOSCOPE PATIENT PROTECTION CAP, SINGLE-USE

Model Number MAJ-2315

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/28/2022

Event Type  Injury  

Event Description

(b)(4): the customer reported during an ercp, the initial passage of the duodenoscope across the pylorus, in the prone position, was not feasible to due to the dilated stomach, body habitus and angulated/deformity at the junction of d1-d2.The endoscope was withdrawn and the patient was placed in the supine position.Subsequently, the scope was traversed to the second portion of the duodenum with some difficulty.The physician was using the endoscope with the distal cover.When the duodenoscope was withdrawn, the distal cover was not attached to the endoscope.According to the physician, nurse and endoscopy technicians, several attempts were made to retrieve the distal cover without success.Three (3) events reported by facility as follows: for event 1 of 3, see (b)(6).For event 2 of 3, see (b)(6).For event 3 of 3, see (b)(6).This is event 2 of 3 from the facility and includes 2 reports: (b)(6): maj-2315.H1y30.(b)(6): tjf-q190v, (b)(4).

• Brand Name: SINGLE USE DISTAL COVER
• Type of Device: ENDOSCOPE PATIENT PROTECTION CAP, SINGLE-USE
• Manufacturer (Section D): OLYMPUS AMERICA, INC; 3500 corporate parkway; center valley PA 18034 0610
• MDR Report Key: 15198985
• MDR Text Key: 297657703
• Report Number: 2429304-2022-00019
• Device Sequence Number: 1
• Product Code: NWB
• 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: 07/12/2022,08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• 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: H1Y30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TJF-Q190V, SERIAL (B)(4)
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 153 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White