MAUDE Adverse Event Report: COOK ENDOSCOPY 6 SHOOTER SAEED MULTI-BAND LIGATOR; MND, LIGATOR, ESOPHAGEAL

Catalog Number MBL-6

Device Problems Premature Activation (1484); Shelf Life Exceeded (1567); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The trigger cord wound on the two-way handle, loading catheter and two (2) deployed black bands were included in the return.The barrel, four (4) bands and irrigation adapter were not included in the return.The handle was returned in the two-way position.A functional test could not be performed due to the condition of the returned device.A visual examination of the device was performed.The trigger cord was examined and all twelve (12) deployment beads were present.The beads were verified for correct location.The beads were examined using magnification and found to be correctly filled and had no evidence of excess flash.The length of the trigger cord was measured within tolerance.An evaluation of the handle wheel movement was performed and the wheel functioned as intended.The trigger cord was intact and not broken.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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: it was observed that the product was used after the expiration date.Use of the product after the stated expiration date could cause the product to underperform.This is a likely cause for the reported observation.Premature band deployment can occur if the handle is placed in the firing position before the endoscope is in place inside the patient or even while winding the trigger cord.The user is advised not to apply tension to the trigger cord while winding it on the handle to avoid premature deployment of bands.The instructions for use caution the user: ¿with handle in two-way position, slowly rotate handle clockwise to wind trigger cord onto handle spool until it is taut.Note: care must be taken to avoid deploying a band while winding trigger cord." another possible contributing factor to premature band deployment includes allowing the trigger cord to become lodged between the barrel and the distal end of the endoscope.This can restrict trigger cord movement and result in premature band deployment if enough tension is applied to pull the cord free.The instructions for use direct the user: "attach barrel to tip of endoscope, ensuring barrel is advanced onto tip as far as possible.Note: when placing the barrel onto the distal end of the endoscope, ensure that the trigger cord does not become pinched between the barrel and the endoscope." rapid rotation of the ligator handle can contribute to premature band deployment.The instructions for use direct the user: ¿maintain suction and deploy band by rotating handle clockwise until band release is felt, indicating deployment." prior to distribution, all 6 shooter saeed multi-band ligators are subjected to a visual inspection to ensure device integrity.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.Additional comments regarding this report: based on the information provided that the device was expired, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

Event Description

During an endoscopic variceal ligation (evl), the physician used a cook 6 shooter saeed multi-band ligator (mbl-6).When the assisting nurse wanted to fire the first band, the band released but [did]not band the bleeding varix [premature band deployment].At this point, the endoscopic suction was switched on.A second band was fired, but all the remaining bands (second band to the sixth band were released immediately) [premature band deployment].The doctor quickly removed the endoscope from the patient's esophagus, and changed to a new mbl-6 unit.The banding procedure was repeated, six (6) bands was successfully fired and banded all the varices.The procedure was done successfully.

• Brand Name: 6 SHOOTER SAEED MULTI-BAND LIGATOR
• Type of Device: MND, LIGATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 7491736
• MDR Text Key: 107865718
• Report Number: 1037905-2018-00188
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 00827002225534
• UDI-Public: (01)00827002225534(17)180221(10)W3832259
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MBL-6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/11/2018
• Device Age: 14 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1