MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS; ROTATABLE GRASPING FORCEPS

Model Number	UNKNOWN
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
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 "endoscopic treatment of intraductal pancreatic stent fragmentation".The literature reported the result of 33 patients with endoscopic treatment of intraductal pancreatic stent fragmentation using unspecified endoscope and olympus rotatable grasping forceps (fg-44nr-1 or fg-v422pr) or electrosurgical snare (sd-9u-1) from 2001 to 2015.In the subject cases, periampullary duodenal bleeding occurred in 2 patients.Therefore, omsc will submit 2 medical device reports (mdr) depending on the device and event type.This report is 1 of 2 reports of rotatable grasping forceps.

• Brand Name: OLYMPUS
• Common Device Name: ROTATABLE GRASPING FORCEPS
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10624704
• Report Number: 8010047-2020-07191
• Device Sequence Number: 17048978
• Product Code: EOQ
• UDI-Device Identifier: 04953170032196
• UDI-Public: 04953170032196
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K962533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/05/2020

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?: No
• Operator of Device: No Information
• Device Model Number: UNKNOWN
• 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: 09/09/2020
• Initial Report FDA Received Date: 10/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other