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

Model Number	D-201-14304
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, omsc presumes that the event occurred since the subject device was attached to the distal end of the endoscope without medical tape, and retention force was reduced.The above device handling has warned in the instruction manual as follows.Do not use vaseline (or any lubricant that contains petroleum jelly), olive oil, alcohol, or the xylocain spray to lubricate the instrument.Doing so could cause equipment damage, or cause the instrument to fall off of the endoscope inside the patient.Be sure to wipe away any excess lubricant before mounting the instrument, and secure the instrument firmly using medical tape with sufficient elasticity.If the instrument is not firmly secured, it could come off inside the body cavity during use and cause patient injury, such as mucous membrane damage.
Event or Problem Description
During a colonic polypectomy, the subject device was used.The subject device fell inside the patient and retrieved with the grasping forceps.The intended procedure was continued with another device.There was no patient injury reported.

• Brand Name: DISPOSABLE DISTAL ATTACHMENT
• Common Device Name: DISPOSABLE DISTAL ATTACHMENT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10634658
• Report Number: 8010047-2020-07282
• Device Sequence Number: 11526666
• Product Code: FDS
• UDI-Device Identifier: 04953170278310
• UDI-Public: 04953170278310
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K984358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: D-201-14304
• Device Lot Number: 9ZK
• 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: 09/16/2020
• Initial Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR