MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED) SINGLE USE PRELOADED SPHINCTEROTOME

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.

• Brand Name: SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED)
• Type of Device: SINGLE 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 Key: 13550369
• MDR Text Key: 290456551
• Report Number: 8010047-2022-03130
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• 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 Received: 02/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: KD-VC411Q-0725
• Device Lot Number: UNKNOWN (LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2022
• 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