MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-10-11 for ETHILOOP SILICON SLING UNKNOWN PRODUCT manufactured by Ethicon Inc..
[123497200]
(b)(4). This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided. Citation: dis colon rectum. 2004; 47: 1874? 1882. Doi: 10. 1007/s10350-004-0650-8. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[123497201]
It was reported via journal article: "title: treatment for horseshoe fistulas-in-ano with primary closure of the internal fistula opening: a clinical and manometric study" authors: andreas koehler, m. D. ; angelika risse-schaaf, m. D. ; sotirios athanasiadis, m. D. Citation: dis colon rectum. 2004; 47: 1874? 1882. Doi: 10. 1007/s10350-004-0650-8. The authors reported on a patient cohort with dorsal horseshoe fistulas-in-ano. The authors sought to answer the question of whether these fistulas can be operatively treated, implementing a sphincter-preserving fistulectomy with primary closure of the internal opening, as is done when treating transsphincteric anal fistulas. From 1985 to 2000, a total of 42 patients (29 men and 13 women; age: 44? 11 years) were operatively treated (52 operations) for horseshoe fistulas-in-ano originating in cryptoglandular regions. During the surgical procedure, after cleansing and curettage of the deep-lying abscess cavity, the authors were able to palpate the pathologic alterations in the opposite ischiorectal fossa, which we had previously discovered during the endosonographic examination. This region was then opened with a counter incision to facilitate optimal drainage of the deep retroanal abscess cavity through placement of ethiloop 2-0 silicon setons (ethicon). These were inserted bilaterally through the internal fistula opening to prevent a premature closure with development of a new abscess. Different operative techniques were done for closure of the internal fistula opening. During the mucosal advancement flap, after excision of the internal fistula opening and evacuation of the cryptoglandular infective focus, a mucosa-submucosa flap with a length of 3 cm and a width of 2 to 3 cm is formed from the rectum proximal to the internal fistula opening. Then, using either vicryl 2-0 (ethicon) or pds sutures (ethicon) the muscular defect is closed. Finally, this supportive suture is covered with the initially mobilized mucosa-submucosa flap using vicryl 2-0 (ethicon) or pds sutures (ethicon). So that the pressure-bearing suture is protected from stool contamination. Same technique is used for the rectal wall advancement flap. In the anocutaneous advancement flap procedure, the muscular defects in the area of the former internal fistula ostium and the locus of penetration in the external sphincter muscle are sutured in the same manner, using the same suture material as above. In the direct closure technique (n-11), first, the muscular defect is closed with vicryl 2-0 (ethicon) or pds sutures (ethicon) and then it is covered with the anoderm/mucosa, which is layered over with vicryl 4-0 (ethicon) or pds sutures (ethicon). In all technique groups, reported complications included fistula recurrence (n-9) which required re-operation in 8 patients, second fistula recurrence (n-2) which required third operation, suture line dehiscence (n-3), fistula recurrence at 7 and 14 months post-operatively (n-2), incontinent for liquid stools (n-6), deterioration in continence (n-12), minor incontinence (n-8), and major incontinence (n-4). Operative treatment of horseshoe fistulas-in-ano may be performed according to the surgical principles of fistulectomy with closure of the internal fistula opening, no severing of the muscular compartments surrounded by the fistula, and use of either endorectal or endoanal flap techniques or direct closure. Direct closure of the internal fistula opening without extensive mobilization may prove to be successful in some cases. In accordance with the authors? Experience, this technique represents a good alternative treatment modality in the group of endoanal closure techniques.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-76477 |
| MDR Report Key | 7957671 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2018-10-11 |
| Date of Report | 2018-09-21 |
| Date Mfgr Received | 2018-09-21 |
| Date Added to Maude | 2018-10-11 |
| 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 | DARLENE KYLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Manufacturer G1 | ETHICON INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHILOOP SILICON SLING UNKNOWN PRODUCT |
| Generic Name | RETAINER, SURGICAL |
| Product Code | GCZ |
| Date Received | 2018-10-11 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-11 |