MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*HCS HEMORR CIR STAPL; STAPLE, IMPLANTABLE

Catalog Number	PPH01
Health Effect - Clinical Codes	Fistula (1862); Pain (1994); Blood Loss (2597); No Code Available (3191)
Date of Event	01/01/2007
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of event: publication year of 2007.Batch # unk.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.(b)(4).
Event or Problem Description
It was reported via literature entitled: primary and repeated stapled hemorrhoidopexy for prolapsing hemorrhoids: follow-up to five years.Authors: dennis raahave, m.D., d.M.Sci., lars v.Jepsen, m.D.And ib k.Pedersen, m.D.Citation: diseases of the colon and rectum; volume 51: 334¿341 (2008); doi: 10.1007/s10350-007-9102-6.This study was designed to assess initial results, analyze complications and failures, and document both the need for repeated procedures and the outcomes of follow-up to five years of stapled hemorrhoidopexy.Between june 8, 1999, and march 21, 2004, 258 patients (male=115, median age 55, range 29-83 years and female n=143, median age 52, range 23-87 years) with second-degree, third-degree, or fourth-degree hemorrhoids underwent modified stapled hemorrhoidopexy.After stretching the anorectal mucosa with forceps, a monocryl 2-0 pursestring suture was placed in the deep submucosa, approximately 3 cm above the dentate line, starting at the 8 o¿clock position and taking the suture anoscope in and out clockwise through the anoscope for every stitch.The staplers used were the eea in 12.7 percent (tycohealthcare, new haven, ct) and the hcs 33 and pph01 (ethicon endo-surgery, inc.) in 87.3 percent.After final closure, the stapling gun was fired and compressed for 2 minutes.Finally, a cylindrical hemostatic sponge (spongostan, ferrosan, copenhagen, denmark) was placed in relation to the staple line.Complications included persisting mucosal prolapse (n=31) in which subsequent surgical excisions were performed; bleeding less than 24 hours postoperative (n=15) in which hemostasis was done in 11 patients and conservative treatment was done in 4; bleeding less than 1 moth postoperative (n=6) in which hemostasis was done in 1 patient and conservative treatment was done in 5; stenosis (n=2) in which dilatation was performed; fissure (n=2) in which dilatation was done in one patient and conservative treatment was given to the other, fistula (n=1) and pain (n=5) which was treated with analgesics.Inspection after stapling revealed a lack of a staple line over some distance (partial stapling), resulting in a corresponding partial persistence of the mucosa prolapse (n=18).Thirteen patients had the prolapse excised, 2 were restapled immediately, and 3 were managed conservatively.One patient had to have a captured stapler head excised.In conclusion, the pain after stapled hemorrhoidopexy was low, recovery was rapid, complications were few, and patient satisfaction was high.A recurrent (or persistent) prolapse was alleviated by a repeated stapled hemorrhoidopexy for cure.However, there was a high risk of reintervention after a stapled hemorrhoidopexy, and this should be further evaluated.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8860137
• Report Number: 3005075853-2019-21049
• Device Sequence Number: 525560
• Product Code: GDW
• UDI-Device Identifier: 10705036012993
• UDI-Public: 10705036012993
• Combination Product (Y/N): N
• PMA/510(K) Number: K030925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: PPH01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention