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

Model Number	MH-588
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned to olympus medical systems corp (omsc).The malfunction of the subject device concerning this case has not been reported.The exact cause could not be determined.If additional information becomes available, this report will be supplemented.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "clinical response to peroral endoscopic myotomy in patients with idiopathic achalasia at a minimum follow-up of 2 years".The literature reported the result of 75 patients with achalasia of the peroral endoscopic myotomy procedure using olympus distal attachment mh-588 from 2010 to 2012.In the subject case, 1 case of dislodged of the subject device occurred, which was successfully treated endoscopically without clinical sequelae.Omsc will submit a medical device report (mdr) depending on the event.

• Brand Name: DISTAL ATTACHMENT
• Common Device Name: 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: 11396949
• Report Number: 8010047-2021-03167
• Device Sequence Number: 4275167
• Product Code: FDS
• UDI-Device Identifier: 04953170364518
• UDI-Public: 04953170364518
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K984358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2021

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: Health Professional
• Device Model Number: MH-588
• 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: 02/22/2021
• Initial Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1