MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD ECH FLEX 60MM 34CM SHAFT; STAPLE, IMPLANTABLE

Catalog Number	PSE60A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Fistula (1862); Hemorrhage/Blood Loss/Bleeding (1888); Nausea (1970); Pain (1994); Vomiting (2144); Restenosis (4576); Swelling/ Edema (4577)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) date sent: 7/18/2025 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.Attempts are being made to obtain the following information.To date, a response has not been received.Should additional information be obtained, a supplemental report will be submitted.Does the author/surgeon believe that the ethicon devices mentioned in this article caused/contributed to the reported events in the article? if yes, please explain.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.
Event or Problem Description
Title:clinical application value of domestic and imported stapler based on real world data analysis authors: wang hongdan, zhang benxing, wei'anhai, yang li, zhang hehua citation: china medical equipment 2024 april vol.21 no.4;doi: 10.3969/j.Issn.1672- 8270.2024.04.030 the aim of this study is to investigate and analyze the clinical use value of imported and domestic brands of staplers based on real world data.A total of 466 patients who received stapler anastomosis in daping hospital of military medical university in 2022 were selected and divided into imported stapler group (n = 294) and domestic stapler group (n = 172) according to different brands of stapler used during operation.In imported stapler group, there were 194 males and 100 females, aged 21-89 years, with mean one of (62.77 ± 11.88) years.The domestic stapler uses qelc and other models of universal endoscopic linear cutter stapler and disposable loading unit (chongqing maikewei medical technology co., ltd.) dec-b160 and other models of disposable endoscopic linear cutter stapler and assembly (jiangsu triple xinghai medical devices co., ltd.) and other 8 brands of multiple specifications; the imported stapler uses johnson & johnson) the staplers and reloads produced by ke hui two companies include pse60a electric linear cutter stapler and reloads (johnson & johnson, usa) and gastrointestinal tract and other models of cavity cutter stapler and disposable reloads (covidien, usa).The mean duration follow-up was not reported.Reported complications: pse60a electric linear cutter stapler and reloads (ethicon): (n=?)defecation and exhaust treatment: not reported (n=?)nausea and vomiting treatment: not reported (n=?) cough with sputum treatment: not reported (n=?) incision pain treatment: not reported (n=?)haemorrhagic/anastomotic bleeding treatment: not reported (n=?) edema treatment: not reported (n=?) stenosis treatment: not reported (n=?) fistula treatment: not reported in conclusions, although this study has some limitations and does not adopt the long-term follow-up data of patients to provide long-term safety evaluation, in terms of intraoperative anastomosis effect, postoperative recovery and economy, the domestic stapler has the application effect equivalent to the imported brand and has irreplaceable price advantage.

• Brand Name: PWRD ECH FLEX 60MM 34CM SHAFT
• 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: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 22544025
• Report Number: 3005075853-2025-05691
• Device Sequence Number: 7013591
• Product Code: GDW
• UDI-Device Identifier: 10705036014324
• UDI-Public: 10705036014324
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110385
• 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): 07/18/2025

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: PSE60A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ECR60UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown