MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-01-23 for LAPRA-TY* APPLIER - 33CM KA200 manufactured by Ethicon Endo-surgery, Llc..
[177768168]
(b)(4). Batch # unk. Date of report: publication year for the journal article is 2017. This report is related to a journal article; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided. Attempts are being made to obtain the following information: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? If yes, please explain. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent.
Patient Sequence No: 1, Text Type: N, H10
[177768169]
It was reported that during review of a journal article, title: proximal leakage after laparoscopic sleeve gastrectomy: an analysis of preoperative and operative predictors on 1738 consecutive procedures. Author/s: giovanni cesana, stefano cioffi, riccardo giorgi, roberta villa1, matteo uccelli, francesca ciccarese, giorgio castello, bruno scotto and stefano olmi. Citation: obes surg (2018) 28:627? 635; doi 10. 1007/s11695-017-2907-z; published online: 24 august 2017. The purpose of this retrospective study was to search for predictive factors for proximal leakage after laparoscopic sleeve gastrectomy (lsg) in a large cohort from a single referral center. From january 2008 to october 2016, one thousand seven hundred and thirty-eight patients (median age 41. 0 (33. 0 to 49. 0) years, male n=428, female n=1310) who underwent laparoscopic sleeve gastrectomy were analyzed. Lsg was performed using four trocars. The great curvature was dissected and isolated from the gastrocolic ligament and the splenocolic ligament through an ultrasonic device (harmonic ace, ethicon endo-surgery inc. , cincinnati, ohio) or a radiofrequency sealer device (ligasure maryland jaw, medtronic, dublin, ireland; or conmed altrus, conmed electrosurgery, centennial, co, usa) or an integrated device of both advanced bipolar energy and ultrasonic energy (thunderbeat, olympus medical system corp. , tokyo, japan). The linear stapler used were covidien endo gia 60 reloads with or without tri-staple technology (medtronic, dublin, ireland) and ethicon echelon flex 60 endopath stapler (ethicon endo-surgery inc. , cincinnati, oh). The choice of a particular cartridge depended on the tissue thickness according to the intra-operative perception and experience of the surgeon. In most of the lsgs, the highest part of the suture was reinforced with an overriding suture: pds 3/0 (mic55e, pds ii, ethicon endo-clip suture, cincinnati, oh, usa) or polysorb 2/0 (endostitch suturing device, covidien, dublin, ireland), or with buttress material: bovine pericardium (peri-strip dry, synovis life technologies, inc. , st. Paul, mn, usa) or polyglycolic acid (endo gi reinforced reloaded with tri-staple technology, medtronic, dublin, ireland). Complications included leakage at the bottom of gastric suture (n=3) which was easily managed by a laparoscopic intervention with suture of the gastric dehiscence; leakage at the proximal part of the gastric suture (n=45), abdominal pain (n=45), fever (n=45) and abdominal abscess (n=42). In conclusion, in this large consecutive cohort study of lsg, proximal staple line reinforcement (buttress material or suture) reduced the risk of a leak.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005075853-2020-00524 |
| MDR Report Key | 9624975 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-01-23 |
| Date of Report | 2020-01-02 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-01-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 475 CALLE C |
| Manufacturer City | GUAYNABO 00969 |
| Manufacturer Postal | 00969 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | ETHICON ENDO-SURGERY, LLC. |
| Manufacturer Street | 475 CALLE C |
| Manufacturer City | GUAYNABO 00969 |
| Manufacturer Postal Code | 00969 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAPRA-TY* APPLIER - 33CM |
| Generic Name | APPLIER, SURGICAL, CLIP |
| Product Code | GDO |
| Date Received | 2020-01-23 |
| Catalog Number | KA200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Manufacturer Address | 475 CALLE C GUAYNABO 00969 00969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-23 |