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

Catalog Number	MBL-6-I-5B-S
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The instructions for use direct the user to place the endoscope tip in a straight position during the loading process.Loading the barrel and trigger cord with the endoscope tip curved can contribute to premature band deployment.Premature band deployment can occur if care is not exercised while loading the device onto the endoscope.The instructions for use direct the user to "slowly rotate the handle clockwise to wind the trigger cord onto the handle spool until it is taut." the instructions advise the user that "note: care must be taken to avoid deploying a band while winding trigger cord." premature band deployment can also occur if the handle is placed in the firing position before the endoscope is in place inside the patient.The instructions for use direct the user "prior to introducing endoscope, keep handle in two-way position." after intubation, the instructions for use direct the user to "place the handle in firing position." rapid rotation of the ligator handle can contribute to premature band deployment.The instructions for use direct the user to "maintain suction and deploy band by rotating handle clockwise until band release is felt, indication deployment." during the procedure, endoscopic suction is applied to the banding site to properly place a ligator band.Premature band deployment can also occur if the handle is rotated before maintaining suction on the banding site.The instructions for use advise the user to maintain suction while deploying the band.If the ligator handle is in the firing position while the endoscope is straightened, this can result in premature band deployment due to tension on the trigger cord.The instructions for use direct the user to "place the handle in two-way position" before straightening the endoscope.The instructions for use direct the user to remove the endoscope and attach a new ligator if more bands are required.Prior to distribution, all 6 shooter saeed multi-band ligator 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.
Event or Problem Description
During an endoscopic procedure, the physician used a cook 6 shooter saeed multi-band ligator.As reported in the doctor letter: "this is to certify that h.Mm and my care of ogd [esophagogastroduodenoscopy] and evl [esophageal varices ligation].Cook band which used in procedure had already broken before use.So please replace it with reg." as reported in dealer letter: "dear sir/madam, we had supplied mbl-6-i-5b-s to (b)(6).During the procedure dr.(b)(6) found faulty product twice.One time the band didn't work properly [mdr 1037905-2016-00160] and another time one band was already outside the instrument open [mdr 1037905-2016-00161].Lot no [number]- w3650928 - didn't work properly.[mdr 1037905-2016-00160].Lot no [number] w3639801- one single band was open from the instrument itself.[mdr 1037905-2016-00161].I am sending both the lot no [number] product.Kindly send us the replacement product.I have attached doctor's complaint letter.Please process this urgently.".

• Brand Name: 6 SHOOTER SAEED MULTI-BAND LIGATOR
• Common Device Name: MND, LIGATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 5689067
• Report Number: 1037905-2016-00161
• Device Sequence Number: 219080
• Product Code: MND
• UDI-Device Identifier: 00827002268616
• UDI-Public: (01)00827002268616(17)161027(10)W3639801
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MBL-6-I-5B-S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/30/2016
• Device Age: 6 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/31/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENDOSCOPE (UNKNOWN TYPE)