MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE 5MM SHEAR; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARXX

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Wound Dehiscence (1154); Abscess (1690); Hemorrhage/Bleeding (1888); Pain (1994); Urinary Retention (2119); Insufficient Information (4580)

Event Date 02/04/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk (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/batch number has not been provided.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.

Event Description

Title: is it possible to reduce recurrences after altemeier¿s procedure for complete rectal prolapse? twenty-year experience in 130 consecutive patients.Authors: paolo boccasanta, marco venturi, sergio agradi, giuseppe calabrò, luca bordoni, claudio missaglia, umberto favetta, contardo vergani citation cite: langenbeck's archives of surgery (2021) 406:1591¿1598.Https://doi.Org/10.1007/s00423-021-02091-2.The present retrospective study reports the long-term results of altemeier¿s operation with levatorplasty and the same procedure associated with tocs, in a large series of patients with cpr.Medical records of 110 patients undergoing altemeier with levatorplasty (group 1) and 20 patients submitted to the same procedure associated with tocs (group 2) for newly diagnosed complete rectal prolapse were reviewed.All patients had been recruited after preoperative clinical examination, sf-36 quality of life, continence score and colonoscopy.Ultracision harmonic scalpel g 300 and coagulating shears 14c (ethicon endo-surgery, inc., cincinnati, ohio) to achieve a tissue dissection without the need of vessel ligatures.Anastomosis between the upper colon and the divided anal ring was performed manually, with interrupted 3/0 vicryl sutures, or mechanically, with different circular staplers, depending on the size of the descending colon.Associated trans-obturator taping(tvt-o) was performed during the altemeier¿s procedure, after the preparation and before the resection of the prolapsed bowel.Vycril mesh was also used during the redo-altemeier.Reported complications included anastomotic dehiscence, pain, perineal abscesses, urinary retention, anal strictures, rectal dyschezia, tenesmus , rectal bleeding, recurrence in conclusion with all the limitations of a retrospective study, the clinical and functional results of our 20-year experience with the altemeier¿s procedure in 130 patients indicate that the procedure is safe and effective for the treatment of crp, even if limited by the non-negligible incidence of anastomotic complications and recurrence rate.The combination of altemeier with tocs showed a positive trend to a reduction of the recurrence rate, not worsening morbidity and outcomes.

• Brand Name: HARMONIC ACE 5MM SHEAR
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 329348013
• MDR Report Key: 15403318
• MDR Text Key: 299758278
• Report Number: 3005075853-2022-05959
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K120729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HARXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention