MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORP. ALLIGATOR JAW-STEP WITH NEEDLE; BIOPSY FORCEPS

Model Number FB-220U.A

Device Problem Difficult To Position (1467)

Patient Problem No Code Available (3191)

Event Date 03/12/2014

Event Type  Injury  

Event Description

Olympus was informed that during a colonoscopy procedure, the physician tried to use the forceps to take a bite, but instead it peeled the mucosal wall of the colon.Minor bleeding was observed and the physician used one clip to seal the bleeding.The procedure was still completed using another device.

Manufacturer Narrative

The facility reported that the forcep was discarded and will not be returned to olympus.The exact cause of the user's experience could not be conclusively determined at this time.If additional information becomes available at a later time, this report will be supplemented.

• Brand Name: ALLIGATOR JAW-STEP WITH NEEDLE
• Type of Device: BIOPSY FORCEPS
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORP.; 2951 isikawa-cho; hachioji-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEM CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 3738882
• MDR Text Key: 20977980
• Report Number: 2951238-2014-00106
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FB-220U.A
• Device Catalogue Number: FB-220U.A
• Device Lot Number: 3YT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2014
• 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
• Patient Outcome(s): Other