MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*PPH PROCEDURE SET; STAPLE, IMPLANTABLE

Catalog Number	PPH03
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via journal article: title: a prospective and comparative study of short term results of open hemorrhoidectomy versus stapled hemorrhoidopexy authors: dr.Reegan jose.M1, dr.Nivedha.R2, dr.Srinidhi.K3 citation:journal of pharmaceutical negative results/ doi: 10.47750/pnr.2022.13.S09.825.The aim of prospective and comparative study was to compare the short term results of stapled hemorrhoidopexy(sh) with open hemorrhoidectomy(oh) with respect to operating time, post-operative pain and immediate post-operative complications.Between june 2014 to august 2015, a total of ninety patients (57 male and 33 female with mean age of 21->60 years old) undergoing surgery for hemorrhoids at srm medical college, kattankulathur ,who fulfilled the criteria were included in the study.Forty five patients underwent milligan morgan technique of open hemorrhoidectomy and forty five patients underwent longo technique of stapled hemorrhoidopexy.The stapled procedure was performed according to the technique described by longo.A 33-mm circular stapling device part of pph03 kit (proximate; ethicon endosurgery, cincinnatti, ohio, usa) was used.The pph03 kit includes all of the required components of the procedure, except for a suture.This anoscope is a semicircular instrument that facilitates the placement of the purse string suture.A purse ¿ string suture of 2/0 polypropylene was inserted at least 4cm above the dentate line, catching only the mucosa and submucosa.Reported complications include : retention (n=7) treatment: not provided.Bleeding (n=5) treatment: not provided.Pain (n=13) treatment: not provided.In summary, the findings to the study confirm that stapled hemorrhoidopexy is associated with shorter duration of surgery, less postoperative pain and need for analgesia, with minimal post-operative complications as compared with milligan ¿ morgan (open )hemorrhoidectomy.There is no recurrence, residual prolapse or incontinence in the follow up period of six months.Stapled hemorrhoidopexy is safe with many short- term benefits.It is a novel technique and has emerged as an alternative to open hemorrhoidectomy , long considered the ¿gold standard¿.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/11/2025.D4: batch # unk.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Common Device Name: STAPLE, IMPLANTABLE
• 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 21576954
• Report Number: 3005075853-2025-01919
• Device Sequence Number: 8225476
• Product Code: GDW
• UDI-Device Identifier: 10705036013006
• UDI-Public: 10705036013006
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K051301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2025

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: PPH03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2025
• Initial Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown