PROXIMATE XR60GRecalls & reported problems

Ethicon Endo-Surgery, LLC · Proximate Linear Stapler Reloads · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705036013471), received between Apr 2, 2020 and Nov 5, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Unsealed Device Packaging” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1
Unsealed Device Packaging1

Patient problems

Failure to Anastomose1
No Consequences Or Impact To Patient1
Not Applicable1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER A COLON PROCEDURE, PATIENT HAD A LEAK. LEAK WAS NOT NOTICED INTRA-OP. HAD TO CLOSE THE BOWEL.
Patient problems: Failure to Anastomose; Not Applicable
MAUDE report 10792445 ↗
MalfunctionApr 2, 2020Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PACKAGING WAS IMPERFECT, THE PACKAGE IS OPENED, IT IS NOT UNDER STERILE STATUS. THE STERILITY WAS COMPROMISED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9916821 ↗

Device details

UDI-DI	`10705036013471`
Brand	PROXIMATE
Model	XR60G
Company	Ethicon Endo-Surgery, LLC
Product code	GDW · STAPLE, IMPLANTABLE
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Apr 7, 2026

Device type (GMDN): Surgical staple loading unit, non-cutting

A unit containing non-bioabsorbable surgical staples (implantable and typically U-shaped lengths of wire made of implant grade metal) designed to be used with a surgical stapler (not included) to mechanically fasten internal tissues together (e.g., the subcuticular closure of skin or the approximation of the ends of bowel) to facilitate healing typically in abdominal, thoracic, gynaecologic, orthopaedic, or plastic and reconstructive surgery. The unit is designed to deploy the staples in multiples (e.g., as a row of staples) and is often referred to as a single-use loading unit (SULU) or reload.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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