MAUDE Adverse Event Report: COOK IRELAND LTD SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE; FER LIGATOR, HEMORRHOIDAL

Catalog Number HMBL-4-TRI

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Code Available (3191); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

F.Yi et al 2011- "combined colonoscopy and three quadrant hemorrhoidal ligation: 1000 cases." conventional colonoscopy was performed under moderate sedation, followed immediately by synchronous three-quadrant hemorrhoidal ligation, using a triview¿ anoscope and short-shot¿ hemorrhoidal ligator (cook endoscopy, winston salem nc).Sixty six patients (6.6 percent) required repeat ligation.

Event Description

Final mdr being submitted due to completion of the investigation on 27-aug-21.

Manufacturer Narrative

Device evaluation: the hmbl-4-tri devices of unknown lot numbers involved in this complaint were not available for evaluation.With the information provided, a document based investigation was conducted.This file was created from the journal article.The file (b)(4) ((b)(4)) was opened to investigate 18 patients (1.8 percent) required elective completion surgical hemorrhoidectomy for persistent symptoms.This file (b)(4) ((b)(4)) was opened to investigate 66 patients (6.6 percent) required repeat ligation for persistent symptoms.Documents review including ifu review: as the hmbl-4-tri of lot number devices are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution hmbl devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As per the instructions for use, ifu0030-7 which informs the user about the potential complications "potential complications associated with anoscopy include, but are not limited to: perforation, infection, haemorrhage.Potential complications associated with sedation include but are not limited to: allergic reaction to medication, hypotension, cardiac arrhythmia or arrest, respiratory depression or arrest.Potential complications associated with hemorrhoidal banding include but are not limited to: hemorrhage, fever, infection, pelvic sepsis, nausea, urinary retention, stricture formation and obstruction.There is no evidence to suggest that the customer did not follow the instructions for use.Root cause review a definitive root cause could not be determined from the available information.However there was no evidence of a failure reported associated with the actual devices.A possible root cause could be attributed to patient pre-existing conditions.As per medical affairs "cook device had been used in this study, so it was related to cook device.However, the persistent symptoms were likely due to patient¿s underlying conditions and the grade of hemorrhoids.The device functionality unlikely caused or contributed to this complication.It was not a serious injury." summary: complaint is confirmed based on customer testimony.The patients outcome is unknown, they required repeat ligation for persistent symptoms, as reported.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the imdrf g code being amended.

Manufacturer Narrative

Device evaluation: the hmbl-4-tri devices of unknown lot numbers involved in this complaint were not available for evaluation.With the information provided, a document based investigation was conducted.The file (b)(4) (report reference number - 001845648-2020-00315) was opened to investigate (b)(4) required elective completion surgical hemorrhoidectomy for persistent symptoms.This file (b)(4) (report reference number - 3001845648-2020-00316) was opened to investigate (b)(4) required repeat ligation for persistent symptoms.Lab evaluation ¿ n/a.Documents review including ifu review: as the hmbl-4-tri of lot number devices are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution hmbl devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As per the instructions for use, ifu0030-7 which informs the user about the potential complications "potential complications associated with anoscopy include, but are not limited to: perforation, infection, haemorrhage.Potential complications associated with sedation include but are not limited to: allergic reaction to medication, hypotension, cardiac arrhythmia or arrest, respiratory depression or arrest.Potential complications associated with hemorrhoidal banding include but are not limited to: hemorrhage, fever, infection, pelvic sepsis, nausea, urinary retention, stricture formation and obstruction.There is no evidence to suggest that the customer did not follow the instructions for use.Image review ¿ n/a.Root cause review: a definitive root cause could not be determined from the available information.However there was no evidence of a failure reported associated with the actual devices.A possible root cause could be attributed to patient pre-existing conditions.As per medical affairs "cook device had been used in this study, so it was related to cook device.However, the persistent symptoms were likely due to patient¿s underlying conditions and the grade of hemorrhoids.The device functionality unlikely caused or contributed to this complication.It was not a serious injury.Summary: complaint is confirmed based on customer testimony.The patients outcome is unknown, they required repeat ligation for persistent symptoms, as reported.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE
• Type of Device: FER LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 10089424
• MDR Text Key: 192259400
• Report Number: 3001845648-2020-00316
• Device Sequence Number: 1
• Product Code: FER
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HMBL-4-TRI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/14/2020
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention