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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

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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pancreatitis (4481)
Event Type  Injury  
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.    post-ercp pancreatitis - (3) : mild and improved in 2 days.   the authors reported use of multiple olympus devices and did not specify which device may have contributed to the mild pancreatitis. Therefore, all devices will be reported. (b)(6): fb-39q; (b)(6): clevercut/kd-vc411q-0725; (b)(6): fb-44u. This is report 2 of 3 (b)(6): clevercut/kd-vc411q-0725.
 
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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 Key13550369
MDR Text Key290456551
Report Number8010047-2022-03130
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,Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received04/07/2022
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

Patient Treatment Data
Date Received: 02/17/2022 Patient Sequence Number: 1
Treatment
FB-39Q, FB-44U
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