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Model Number G49197
Device Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/16/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: electrosurgical generator, unknown make and model. Occupation: non-healthcare professional. Investigation evaluation: an evaluation of the photos provided confirmed the report that the cutting wire broke. The photos confirm the product lot number on the pouch and the broken cutting wire at the distal end of the device. A portion of the cutting wire appears to have detached. Our laboratory evaluation of the returned device said to be involved determined that a portion of the device was missing. A visual examination of the distal end of the returned device showed that the cutting wire had broken. The cutting wire had kinked and a portion measuring approximately 11 mm was missing and not included in the return of the device. The cutting wire shows evidence of cautery application. The catheter shows no kinks/bends. A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed. The device history record for the lot number said to be involved was reviewed. A discrepancy or anomaly was not observed with the product that was released for distribution. Investigation conclusion: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting. Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis. This limits our ability to conclusively determine a cause. A broken cutting wire can occur if the tip of the device is over flexed. The instructions for use caution the user: "do not over flex or bow tip beyond 90 degrees, as this may damage or cause cutting wire to break. " cutting wire breakage can occur if the handle is manipulated with the catheter in a coiled position or with the precurved stylet inside the cannulating tip. The instructions for use advise the user to: ¿upon removing device from package, uncoil and straighten sphincterotome. " the user is then instructed to: ¿carefully remove precurved stylet wire from cannulating tip. " the instructions for use contain the following comment: "note: do not exercise handle while device is coiled or precurved stylet is in place, as this may cause damage to the sphincterotome and render it inoperable. " cutting wire breakage can also occur if the cutting wire makes contact with the endoscope when electrosurgical current is applied to perform the sphincterotomy. The instructions for use caution the user: "when applying current, ensure cutting wire is completely out of endoscope. Contact of cutting wire with endoscope may cause grounding, which can result in patient injury, operator injury, a broken cutting wire and/or damage to endoscope. " if the elevator of the endoscope remains in the closed/up position when retraction of the sphincterotome is attempted and additional pressure is applied, this could contribute to cutting wire breakage. The instructions for use caution the user: "elevator should remain open/down when advancing or retracting sphincterotome. " this activity will aid in device preservation. Prior to distribution, all tri-tome pc protector sphincterotomes are subjected to a visual inspection and functional test to ensure device integrity. The functional test includes bowing the sphincterotome to ensure the distal end responds to handle manipulation. A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment. Corrective action: a review of the complaint history was conducted. The likelihood of occurrence is considered rare. Corrective action is not warranted at this time based on the quality engineering risk assessment. Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Event Description
During a stone removal procedure, the physician used a cook tri-tome pc protector sphincterotome. The cutting wire broke once the device was electrified [cutting wire broke in one location]. The user detected the broken under view of endoscopy. The user changed to another same device immediately to complete the procedure. There was no reportable information at this time. The device was evaluated on (b)(6) 2019: the device was missing a portion of the cutting wire. The initial reporter stated that a section of the device did not remain inside the patient¿s body; however the location of the missing section detected during our laboratory evaluation is unknown. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Manufacturer (Section D)
4900 bethania station rd
winston-salem NC 27105
Manufacturer (Section G)
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
scottie fariole
4900 bethania station rd
winston-salem, NC 27105
MDR Report Key8744197
MDR Text Key152096966
Report Number1037905-2019-00356
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/09/2020
Device Model NumberG49197
Device Catalogue NumberTRI-25M-P
Device Lot NumberW3993673
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial