MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-07-31 for SHORTSHOT SAEED HEMORRHOIDAL LIGATOR WITH TRIEVIEW ANOSCOPE HMBL-4-TRI manufactured by Cook Ireland Ltd.
[3676867]
Pt experienced pain after the initial procedure on (b)(6) 2013. Pt called in to the office on (b)(6) 2013 for protruding hemorrhoids. Doctor recommended the pt use cold compress and ointment, and call back if symptoms did not improve. On (b)(6) 2013 the pt called back in with pain, expressing concern that this may be a complication. The doctor recommended add'l ointment and a warm bath, and to call back if symptoms did not improve. On (b)(6) 2013 the pt called back into the office, still in pain. Pt came in for an appointment with the doctor at 12:15pm. Doctor saw potentially thrombosed hemorrhoids and was referred to a surgeon. Pt went into surgery on (b)(6) 2013. Thrombosed hemorrhoids were removed. On (b)(6) 2013 the pt was admitted through the emergency room and underwent a diverting colostomy, infected anal abscess. As of (b)(6) 2013, the pt is in the intensive care unit on a ventilator undergoing daily debridement.
Patient Sequence No: 1, Text Type: D, B5
[10915497]
The customer reported the following complaint "thrombosed hemorrhoids". The device involved in this complaint was not returned for evaluation. Therefore, the customer's complaint cannot be confirmed and the cause of the complaint could not be conclusively determined. With the info provided a document based investigation was carried out. The following clinical review comments were rec'd in relation to this complaint "diverting colostomy seems severe. Seems more likely a potential complication of hemorrhoidectomy rather than a result of banding. It is stated the hemorrhoids were protruding, contraindication is external hemorrhoids. " the shortshot saeed hemorrhoidal multiband ligator with triview anoscope is used to ligate internal hemorrhoids facilitated by an anoscope, for use in adult pts only as per instructions for use that accompanies this device (ifu0030-4). As per precautions section of ifu "hemorrhoidal banding may result in severe pain if the procedure is performed below the dentate line". The pt did not have any pre-existing conditions that could have contributed to this occurence. As per the complaint description: pt was admitted through the emergency room and underwent a diverting colostomy, infected anal abscess. As per potential complications section of ifu0030-4 "potential complications associated with hemorrhoidal banding include but are not limited to: haemorrhage, fever, infection, nausea, urinary retention, stricture formation and obstruction". Thrombosed hemorrhoids were possibly a complication of the hemorrhoidectomy rather than a result of the banding completed with the cirl device. These adverse effects occurred post procedure. However, as the conditions of device usage cannot be replicated, the root cause cannot be conclusively determined. Also, as per clinical input provided "it would be difficult to clearly state that the device (and procedure in which it was used) did not somehow cause or contribute to these events. " the device involved in this complaint is a hmbl-4-tri device. The lot# of the hmbl-4-tri device was not provided; therefore it was not possible to check if any of the affected lot remained in stock. Prior to distribution, all hmbl-4-tri devices are subjected to visual inspection and functional checks to ensure device integrity. The lot# of the hmbl-4-tri device was not provided. Therefore, it was not possible to conduct a review of the relevant mfg records. The 2 year complaint history has been reviewed and this complaint represents an isolated occurrence for the above rpn and product family. Quality engineering assessed the complaint using the health risk assessment (hra) scale and the overall risk has been determined to be moderate. No corrective action is warranted at this time. Customer quality assurance will continue to monitor complaints of this nature for potential emerging trends.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3001845648-2013-00070 |
| MDR Report Key | 3266336 |
| Report Source | 06 |
| Date Received | 2013-07-31 |
| Date of Report | 2013-07-02 |
| Date of Event | 2013-06-18 |
| Date Mfgr Received | 2013-07-02 |
| Date Added to Maude | 2013-08-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANNEMARIE BEGLIN, CQ SUP |
| Manufacturer Phone | 61250473 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHORTSHOT SAEED HEMORRHOIDAL LIGATOR WITH TRIEVIEW ANOSCOPE |
| Generic Name | FER LIGATOR, HEMORRHOIDAL |
| Product Code | FER |
| Date Received | 2013-07-31 |
| Catalog Number | HMBL-4-TRI |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK IRELAND LTD |
| Manufacturer Address | LIMERICK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-07-31 |