• 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 SPHINCTEROTOME V (DISTAL WIREGUIDED) SINGLE USE PRELOADED SPHINCTEROTOME

  • 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 SPHINCTEROTOME V (DISTAL WIREGUIDED) SINGLE USE PRELOADED SPHINCTEROTOME Back to Search Results
Model Number KD-VC411Q-0725
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation. The investigation is in process. Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
 
Event Description
Olympus reviewed the following literature article: "factors affecting the yield of endoscopic transpapillary bile duct biopsy for the diagnosis of pancreatic head cancer" by hirokazu kimura, et al. The study was aimed to identify factors associated with a positive outcome using transpapillary biliary biopsy (tbb) for pancreatic head cancer (phc). Total 130 cases that underwent tbb for investigation of distal biliary stricture were included [62 cases of phc, 36 cases of distal biliary cancer (dbc), and 32 cases of benign biliary stricture (bbs)], and the factors affecting the diagnostic efficiency of tbb were determined using univariate and multivariate logistic analyses. The study reported that endoscopic biliary forceps biopsy showed a carcinoma component in 31 (50%) of 62 phc cases, 33 (91. 7%) of 36 dbc cases, and none of the bpm cases. The cancer-positive rate for dbc was significantly higher than that for phc (p < 0. 01). No complications other than three (one case (1. 61%) of 62 phc and two cases (5. 56%) of 36 dbc) cases of post-ercp pancreatitis were reported. The study concluded with the suggestion that phc with a high level of serum bilirubin (>10 mg/dl) and a high circumferential proportion of bile duct invasion (>2/3 judging by mdct) was a good indication for biliary biopsy. The authors reported: post-ercp pancreatitis - (3) : mild and improved in 2 days. The adverse events were submitted as follows: (b)(6): fb-39q. (b)(6): clevercut/kd-vc411q-0725. (b)(6): fb-44u. Upon follow up with the author, he stated: in rare cases, malfunctions with biopsy forceps were already reported to the olympus staff at our hospital each time. For example, the forceps did not spread well, and the wire was broken. The author did not specify which biopsy forceps did not spread well. This article includes additional reports as follows: (b)(6): fb-39q is for the forceps that did not spread well. (b)(6): fb-44u- is for the forceps that did not spread well. (b)(6): clevercut/kd-vc411q-0725 is for the broken wire. This report is 6 of 6 for (b)(6): clevercut/kd-vc411q-0725 is for the broken wire.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED)
Type of DeviceSINGLE USE PRELOADED SPHINCTEROTOME
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key13889821
MDR Text Key297578217
Report Number8010047-2022-04950
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Study,Literature,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberKD-VC411Q-0725
Device Lot NumberUNKNOWN (LITERATURE)
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/09/2022
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

-
-