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 Pain (1994); No Information (3190)

Event Date 09/11/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient required hospital stay after procedure due to pain post procedure.Initial correspondence from rep on the 12102020-lbe01.Rep received a complaint today (12 october 2020) regarding the shortshot saeed hemorrhoidal multi-band ligator with triview anoscope.The complaint came from (b)(6), but this hospital did not use the product.A nurse at (b)(6) passed on this feedback to me from (b)(6) hospital who did use the product.The feedback is that the (b)(6) site have had post procedural issues following use of the shortshot.One patient ended up with serious bleeding and another required hospital stay afterwards.Description- shortshot saeed hemorrhoidal multi-band ligator with triview anoscope.Initial complaint came from (b)(6), but this hospital did not use the product.Cook rep was advised by a nurse from this establishment.Product used by (b)(6) hospital.(b)(6) site have had post procedural issues following use of the shortshot.Two issues with two separate patient.This file was created to capture the patient who required hospitalization, an additional file was created to capture the patient who suffered bleeding.

Manufacturer Narrative

Component code (annex g): g07001.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.It should be noted that after multiple attempts to gather information no response was received and therefore the standard list of questions were not requested.As the hmbl-4-tri lot number is 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, 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: haemorrhage, 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 a device malfunction.As per clinical input received "pain is also one of the common aes of hmbl.This post procedural pain was likely related to device.I understand that there was no malfunction of the device, however, from a ra perspective shown as below, pain was still a complaint which was likely related to the device." (clinical input) a possible root cause could be attributed to the procedure.Summary: complaint is confirmed based on customer testimony.According to the initial reporter, the patient suffered pain post procedure requiring an additional hospital stay.It is unknown what the patient outcome was or if any additional procedures were required.Should this information become available, the file will be updated accordingly.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation into this complaint and an update to the investigation conclusions.Initial report details: patient required hospital stay after procedure due to pain post procedure.Initial correspondence from rep on the 12102020-lbe01.Rep received a complaint today (12 october 2020) regarding the shortshot saeed hemorrhoidal multi-band ligator with triview anoscope.The complaint came from hobson healthcare ¿ sydenham, but this hospital did not use the product.A nurse at hobson healthcare ¿ sydenham passed on this feedback to me from hobson healthcare ¿ (b)(6) hospital who did use the product.The feedback is that the hobson healthcare - altona site have had post procedural issues following use of the shortshot.One patient ended up with serious bleeding and another required hospital stay afterwards.¿ description- shortshot saeed hemorrhoidal multi-band ligator with triview anoscope.¿ initial complaint came from hobson healthcare ¿ sydenham, but this hospital did not use the product.Cook rep was advised by a nurse from this establishment.Product used by (b)(6) hospital.Altona site have had post procedural issues following use of the shortshot.Two issues with two separate patient.This file was created to capture the patient who required hospitalization, an additional file was created to capture the patient who suffered bleeding.

• 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
• MDR Report Key: 10813876
• MDR Text Key: 217657227
• Report Number: 3001845648-2020-00837
• Device Sequence Number: 1
• Product Code: FER
• Combination Product (y/n): N
• PMA/PMN Number: K060623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HMBL-4-TRI
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/11/2020
• Event Location: Hospital
• Date Manufacturer Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization