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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ENDOLOOP LIGATURE UNKNOWN PRODUCT; LAPROSCOPE, GENERAL & PLASTIC SURGERY
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ETHICON INC. ENDOLOOP LIGATURE UNKNOWN PRODUCT; LAPROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ectopic Pregnancy (1819); Pain (1994)
Event Date 05/26/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? product code and lot numbers involved, if 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 number has not been provided.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: journal of gynecologic surgery volume 36, number 3, 2020 mary ann liebert, inc.Doi: 10.1089/gyn.2019.0124.
 
Event Description
Title: is distal partial salpingectomy with an endoloop ligature safe, fast, and effective for nonisthmic tubal ectopic pregnancy in low-socioeconomic status countries? in this controlled, comparative observational trial, 54 patients with nonisthmic tubal (fimbrial or ampullary) pregnancies received laparoscopic salpingectomies, from may 2015 to december 2018, in the department of obstetrics and gynecology, of (b)(6) hospital, in (b)(6).The study was approved by the hospital¿s institutional review board.The procedures were performed by the same surgeon ((b)(6) assisted by (b)(6)).The patients were counseled regarding partial distal salpingectomy using an endoloop ligature (group 1) or total salpingectomy using bipolar diathermy (group 2).Salpingectomy was performed for group 1 using an endoloop ligature (made with polydioxanone [pds] ii a, violet monofilament; ethicon.Salpingectomy was accomplished by application of the endoloop over the mesosalpinx and broad ligament of the affected part of the fallopian tube (partial distal salpingectomy).The loop was placed under the mass on the uterine side so that the removed part was from the fimbria through the end of the conceptus swelling in proximal end of the fallopian tube near the uterine side.Hemostasis was achieved by looping the ligature over the affected fallopian tube under direct vision and advancing the plastic sheath to tighten the pretied knot.The ligature was easy to use and quickly achieved hemostasis with an excellent tourniquet effect.There was no risk of thermal injury with this technique.Reported complications included repeated ectopic pregnancy contralateral (n=1), low postop pain.In conclusion performing distal partial salpingectomy using an endoloop ligature is a safe, rapid, and effective procedure, compared to electrosurgical total salpingectomy.Further studies are still needed to support distal partial salpingectomy as a recommended treatment.
 
Manufacturer Narrative
Product complaint # (b)(4).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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? product code and lot numbers involved, if 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 number has not been provided.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: journal of gynecologic surgery volume 36, number 3, 2020 mary ann liebert, inc.Doi: 10.1089/gyn.2019.0124.
 
Event Description
Title: is distal partial salpingectomy with an endoloop ligature safe, fast, and effective for nonisthmic tubal ectopic pregnancy in low-socioeconomic status countries? in this controlled, comparative observational trial, 54 patients with nonisthmic tubal (fimbrial or ampullary) pregnancies received laparoscopic salpingectomies, from may 2015 to december 2018, in the department of obstetrics and gynecology, of zagazig university hospital, in cairo, egypt.The study was approved by the hospital¿s institutional review board.The procedures were performed by the same surgeon (m.F.Selim assisted by m.M.A.Abdou).The patients were counseled regarding partial distal salpingectomy using an endoloop ligature (group 1) or total salpingectomy using bipolar diathermy (group 2).Salpingectomy was performed for group 1 using an endoloop ligature (made with polydioxanone [pds] ii a, violet monofilament; ethicon.Salpingectomy was accomplished by application of the endoloop over the mesosalpinx and broad ligament of the affected part of the fallopian tube (partial distal salpingectomy).The loop was placed under the mass on the uterine side so that the removed part was from the fimbria through the end of the conceptus swelling in proximal end of the fallopian tube near the uterine side.Hemostasis was achieved by looping the ligature over the affected fallopian tube under direct vision and advancing the plastic sheath to tighten the pretied knot.The ligature was easy to use and quickly achieved hemostasis with an excellent tourniquet effect.There was no risk of thermal injury with this technique.Reported complications included repeated ectopic pregnancy contralateral (n=1), low postop pain.In conclusion performing distal partial salpingectomy using an endoloop ligature is a safe, rapid, and effective procedure, compared to electrosurgical total salpingectomy.Further studies are still needed to support distal partial salpingectomy as a recommended treatment.
 
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Brand Name
ENDOLOOP LIGATURE UNKNOWN PRODUCT
Type of Device
LAPROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
MDR Report Key12738224
MDR Text Key285258141
Report Number2210968-2021-10735
Device Sequence Number1
Product Code GEA
Combination Product (y/n)N
PMA/PMN Number
K925914
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Type of Report Initial
Report Date 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received10/18/2021
Patient Sequence Number1
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