MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE DISTAL ATTACHMENT

Model Number D-201-11804

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined.If additional information becomes available at a later time, this report will be supplemented.Silva, l.C., arruda, r.M., botelho, p.F.R.Et al.Cap-assisted endoscopy increases ampulla of vater visualization in high-risk patients.Bmc gastroenterol 20, 214 (2020).Https://doi.Org/10.1186/s12876-020-01361-5.

Event Description

Olympus received notification of literature titled "cap-assisted endoscopy increases ampulla of vater visualization in high-risk patients." the purpose of the study was to compare the rates of complete visualization of the ampulla of vater (av) using a cap assisted endoscopy (cae) approach to standard forward-viewing endoscopy (fve).Esophagogastroduodenoscopy (egd) for av visualization was performed in 102 study patients >18 years old using fve followed by cae.Video recordings were blinded and randomly selected for independent expert endoscopic evaluation.Patient demographics: median age (years) 41.7+/- 14.4 and median body mass index (bmi) (kg/m2) 25.3+/-5.6).Of the study population, 62 were females.It was reported that during egd, cap displacement occurred in one patient.Per the literature, the cap was promptly recovered using biopsy forceps.

• Brand Name: DISPOSABLE DISTAL ATTACHMENT
• Type of Device: DISPOSABLE DISTAL ATTACHMENT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10517256
• MDR Text Key: 225396294
• Report Number: 8010047-2020-06399
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170278280
• UDI-Public: 04953170278280
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K984358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-201-11804
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1