MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUS REUSABLE LOOP CUTTER

Model Number FS-5L-1

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2014

Event Type  Other  

Event Description

Olympus was informed that during an esophagogastroduodenoscopy procedure, the user attempted to remove sutures from an unspecific location inside the patient.The loop cutter became stuck on the sutures.The loop cutter was moved with biopsy forceps.There was no patient injury reported.

Manufacturer Narrative

The device has not yet been returned to olympus for evaluation.The exact cause of the user's experience could not be conclusively determined at this time.However, based on the information provided, the reported phenomenon appears to be due to user error, as the device is not intended to cut sutures.(b)(4).

• Brand Name: OLYMPUS REUSABLE LOOP CUTTER
• Type of Device: LOOP CUTTER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi; tokyo 192-8 507; JA 192-8507
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEMS CORPORATION; 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: 3688093
• MDR Text Key: 22263546
• Report Number: 2951238-2014-00069
• Device Sequence Number: 1
• Product Code: HIN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FS-5L-1
• Device Catalogue Number: FS-5L-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention