FDA Adverse Event Malfunction Summary report: N

PROXIMATE*HCS HEMORR CIR STAPL (EXACT CODE UNKNOWN

MDR report key: 8816858 · Received July 23, 2019

Report

Report Number: 3005075853-2019-20668
Event Type: Malfunction
Date Received: July 23, 2019
Report Date: June 28, 2019
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: GDW
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DATE OF EVENT: 2007. BATCH # UNKNOWN. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

Description of Event or Problem · 1

IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: STAPLED HEMORRHOIDOPEXY HEIGHT AS OUTCOME INDICATOR. AUTHOR/S: R. WILLIAMS, M.D.,* L. KONDYLIS, R.N., B.S., D. GEISLER, M.D., P. KONDYLIS, M.D. CITATION: THE AMERICAN JOURNAL OF SURGERY (2007); 193:336¿340. DOI: 10.1016/J.AMJSURG.2006.09.015. THE PURPOSE OF THE STUDY WAS TO EVALUATE HOW OUTCOME IS AFFECTED BY STAPLE LINE HEIGHT (SLH) ABOVE THE DENTATE LINE AND SPECIMEN HISTOLOGY. ONE-HUNDRED FIVE CONSECUTIVE PATIENTS (62 MALE AND 43 FEMALE; AGE RANGE: 25-87 YEARS) THAT UNDERWENT STAPLED HEMORRHOIDOPEXY WERE ANALYZED. ALL PATIENTS UNDERWENT SURGERY IN THE PRONE JACKKNIFE POSITION, AND A 33-MM PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER (ETHICON) WAS USED. REPORTED COMPLICATIONS INCLUDED AN INCOMPLETE SPECIMEN RING (N-1), BLEEDING OR HEMATOMA FORMATION (N-4), POOR PAIN CONTROL (N-3), FECAL IMPACTION (N-1), EPISODE OF DELAYED-ONSET OF SUBCUTANEOUS EMPHYSEMA (N-1), AND ¿COMPLETELY INTACT STAPLE LINE IN ALL BUT 1 PATIENT¿. IN CONCLUSION, HEMORRHOIDOPEXY SLH AND HISTOLOGY CAN IMPACT POSTOPERATIVE OUTCOMES. SLH SHOULD BE >20 MM YET =<40 MM ABOVE THE DENTATE, AVOIDING SQUAMOUS EPITHELIUM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
612074	PROXIMATE*HCS HEMORR CIR STAPL (EXACT CODE UNKNOWN	STAPLE, IMPLANTABLE	GDW	ETHICON ENDO-SURGERY, LLC.

Patients

Seq	Age	Sex	Outcome	Treatment
1