MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-12-21 for SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE HMBL-4-TRI manufactured by Cook Ireland Ltd.
[62912818]
The device involved in this complaint has just recently been returned for evaluation. This evaluation and investigation is still in progress. A follow up report will be submitted within 30 days with the investigation conclusions.
Patient Sequence No: 1, Text Type: N, H10
[62912819]
After placement of the last band, the device would not detach from the rectum. The device detached after suction was removed. The clear plastic tip remained in-situ and had to be removed with snare.
Patient Sequence No: 1, Text Type: D, B5
[65478346]
The customer reported the following complaint issue "after placement of the last band, the device would not detach from the rectum. The device detached after suction was removed. The clear plastic tip remained in-situ and had to be removed with snare. The patient did not require any additional procedure due to this occurrence. No adverse effect was reported due to this occurrence.? Additional information was gathered:? Can you confirm if there was a delay in the procedure as a result of the tip been removed? Yes. The procedure was delayed as the tip needed to be retrieved. How was the snare used to remove the device, did they break the device to remove the tip? From what i understand a jumbo snare was looped over the tip in situ and tightened. They were then able to pull the tip off the mucosa. The tip and snare were not broken. Would this occurrence have led to harm of the patient? Not in this case, as the tip was successfully removed.? The hmbl-4-tri device of lot c1275838 involved in this complaint was returned to (b)(4) and a lab evaluation was held on 16 jan 2017. During the lab evaluation it was noted that the tip was detached from the device, the tip was easily clipped/snapped back on. The device was opened up during the lab evaluation to check that the suction port/ valve was not blocked/ was working correctly. The suction port/valve was confirmed to be free from blockage or obstruction; a wire was passed through to verify the absence of blockage and photographed. This suction port is used to maintain or release suction during use; the customer covers the port with their finger to maintain suction and uncovers the port to reduce suction and release the tissue from the tip of the device. It was noted that the device functioned as expected during the lab evaluation and was free from defects that may have contributed to this occurrence. It was also noted that, given the event description where the customer states that "the device detached after suction was removed", the most probable root cause of this complaint would be attributed to user error as the customer most likely did not release suction at the suction port/valve. However this cannot be conclusively determined as the exact conditions of use could not be replicated in the laboratory setting. The complaint was confirmed based on customer testimony. According to the complaint description "the device would not detach from the rectum. The device detached after suction was removed". It should be noted that the device is designed to remain attached to the haemorrhoid until the suction has been removed. As stated in the instructions for use (ifu), the user is instructed to "uncover suction port of ligator to relieve suction on haemorrhoid. This will allow ligated haemorrhoid to be released from tip of device" it is likely that trying to remove the device while suction remained on may have contributed to the plastic tip detaching from the device; however as the exact conditions of use are unknown, this cannot be conclusively determined. The root cause of this complaint could not be conclusively determined. Prior to distribution, all hmbl devices are subjected to visual inspection and functional checks to ensure device integrity. The shortshot saeed hemorrhoidal multiband ligator with triview anoscope is used to ligate hemorrhoids facilitated by an anoscope. As per the notes section of the ifu? If the package is opened or damaged when received, do not use. Visually inspect with particular attention to joints, cracks or breaks. If an abnormality is detected that would prohibit proper working condition, do not use.? A review of the manufacturing records for the hmbl device involved in this complaint ((b)(4)) did not reveal any discrepancies that could have contributed to the complaint issue. There is no evidence to suggest that this issue affects the entire lot # c1275838; upon review of complaints this failure mode has not occurred previously with this lot # c1275838. Complaints of this nature will continue to be monitored for potential emerging trends.
Patient Sequence No: 1, Text Type: N, H10
[65478347]
This follow up report is being submitted due to the evaluation of the device involved in this event and the conclusion of this investigation. Initial description submitted as follows: after placement of the last band, the device would not detach from the rectum. The device detached after suction was removed. The clear plastic tip remained in-situ and had to be removed with snare.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001845648-2016-00380 |
| MDR Report Key | 6192541 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-12-21 |
| Date of Report | 2016-12-21 |
| Date of Event | 2016-11-28 |
| Date Facility Aware | 2016-11-28 |
| Date Mfgr Received | 2016-11-30 |
| Device Manufacturer Date | 2016-09-21 |
| Date Added to Maude | 2016-12-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SINEAD QUAID |
| Manufacturer Street | O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK |
| Manufacturer City | LIMERICK |
| Manufacturer Phone | 061334440 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE |
| Generic Name | FER LIGATOR, HEMORRHOIDAL |
| Product Code | FER |
| Date Received | 2016-12-21 |
| Catalog Number | HMBL-4-TRI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 68 DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK IRELAND LTD |
| Manufacturer Address | O HALLORAN ROAD LIMERICK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-21 |