• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE Back to Search Results
Model Number KD-640L
Device Problems Break (1069); Difficult to Insert (1316); Material Too Rigid or Stiff (1544); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/15/2018
Event Type  malfunction  
Manufacturer Narrative
The reported device was not returned to olympus; therefore, the cause of the reported event could not be confirmed. However, if additional information becomes available or if the device is returned at a later date, this report will be supplemented accordingly.
 
Event Description
Olympus was informed that at the end of a per oral pyloromyotomy (pop) procedure, the tip of the knife and a piece of the stem was observed missing from the device. An egd-esophagogastroduodenoscopy and fluoroscopy were performed to determine the location of distal end/knife and it added an additional 20-30 minutes under anesthesia for these extra procedures. The device fragments were retrieved from the patient's stomach using biopsy forceps. The intended procedure was completed and there was no patient injury reported. No devices or equipment were replaced. In addition, the device was visually inspected by the nurse and the physician prior to insertion into of device into an olympus 190 scope (model not specified); no anomalies were noted. Per the physician, the knife was noted to be slightly stiff to insert. However, there was no restriction of the scope and no difficulty withdrawing knife from scope. No sparking was observed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSINGLE USE ELECTROSURGICAL KNIFE
Type of DeviceSINGLE USE ELECTROSURGICAL KNIFE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key8143240
MDR Text Key130048654
Report Number2951238-2018-00745
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberKD-640L
Device Lot Number87K
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/15/2018
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

-
-