FDA Adverse Event Malfunction Summary report: N

ECHELON 60MM REINFORCEMENT

MDR report key: 11821747 · Received May 13, 2021

Report

Report Number: 3005075853-2021-02692
Event Type: Malfunction
Date Received: May 13, 2021
Date of Event: April 15, 2021
Report Date: April 16, 2021
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: OXC
UDI-DI: 10705036023296
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). BATCH # UNK. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE. 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. WHY IS IT BELIEVED THAT THE SLR CAUSED THE REPORTED EVENT? ON WHAT NUMBER FIRING DID ISSUE OCCUR? DOES THE SURGEON PULSE FIRE OR USE ONE CONTINUOUS FIRING STROKE? WAS THE TISSUE THICK THAT WAS BEING TRANSECTED? DOES THE SURGEON ROUTINELY WAIT 15 SECONDS PRIOR TO FIRING? IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY AFTER FIRING IT WAS NOTED THAT THE THIRD ROW OF STAPLES ON THE PATIENT SIDED WERE MISSING. THE SURGEON USED CLIPS AND OVER SEWED TO ADDRESS THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
715783	ECHELON 60MM REINFORCEMENT	SURGICAL MESH	OXC	ETHICON ENDO-SURGERY, LLC.			10705036023296

Patients

Seq	Age	Sex	Outcome	Treatment
1