MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON ENDOPATH STAPLER; STAPLE, IMPLANTABLE

Catalog Number ECXXX

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Blood Loss (2597); Foreign Body In Patient (2687); No Code Available (3191)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Date sent: 12/10/2019.Batch # unk.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.Additional information was requested, and the following was obtained: how was the stapler used in the initial procedure? please provide a timeline of events.What is meant by partial hysterectomy? please provide details of what was done in initial procedure.How was the vaginal cuff created? was the stapler used to create the vaginal cuff? i do not have access to any op reports.I can only say that it was likely a typical lavh that i used ethicon endo gia stapler for pedicles but sewed the cuff as my typical technique.I did not use the stapler to close cuff but absorbable suture.I have never encountered such a case of staple migration into cuff not just once, but she has problem again now with a submucosal staple causing pain and bleeding per patient.Her ob gyn who did a partial vaginectomy to remove staple(s) first time about a year ago wants to do another surgery to help symptoms but will remove a lot of vagine per patient.Also, patient states at original surgery she was opened up and was told it was mess and had to take a lot of staples out??? my experience is that staples do not removal only rarely if causing problems.My interest in this is to find out if even if everything goes well in surgery with stapler is there any reports of loose staples migrating in this case into the cuff.Even if was a staple in cuff my concern was why was just not removed but instead led to surgery that led to partial vaginectomy.Unfortunately, i cannot and would not ask for records to review so this is just for my education to understand if staple migration is a risk.

Event Description

It was reported that a patient three- or four-year post-operative after a partial hysterectomy had complications.The patient¿s recovery was unremarkable.Around a year or so later the patient was having painful intercourse and some bleeding.After an examination it was discovered that she had residual staples in her vaginal cuff from the initial procedure.The surgeon was informed about this from the patient who is a friend of his.He was not involved with the patient¿s issues that occurred after the initial procedure.He was not notified by the patient that she was having issues.The patient went to a different physician who was going to remove more staples and, in the process, had to remove more of the patient¿s vagina.With in a year of this procedure she had to have more staples removed and more of her vagina was removed.Patient is still experiencing some bleeding occasionally.According the reporting surgeon staples are still migrating into her vagina.

• Brand Name: ECHELON ENDOPATH STAPLER
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9445577
• MDR Text Key: 188193744
• Report Number: 3005075853-2019-24142
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• PMA/PMN Number: K051002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ECXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention