MAUDE Adverse Event Report: FEMSELECT LTD. ENPLACE; FIXATION, NON-ABSORBABLE FOR PELVIC USE

Model Number ENPLACE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/24/2023

Event Type  Injury  

Event Description

Patient undergone enplace repair and developed an apical failure in a matter of weeks.After a long discussion of management options, she elected for enplace once again.Of note, anatomically, her uterus was very atrophic.I was convinced that the failure was due to lack of adequate tissue bites of the cervix with the suture.As such, on the repeat, i made greater effort to involve the cervix in the passes of needle by taking more substantial bites.In the end of the case, there was excellent lift of the apex tissue.I was told about 4-5 days later that she had been admitted with sbo.The surgeon found that the suture had caught a short segment of the ileum.The was excised and repaired.She is now recovering well.Case date: (b)(6) 2023.Facility: (b)(6).The patient injury occurred during the hysteropexy procedure, which is not device related.The suture placement through the small bowel could have occurred, regardless of the approach for sacrospinus ligament suture placement.The small bowel injury occurred during the suspension of the cervix which is a routine step in hysteropexy, regardless of surgical tools employed.

• Brand Name: ENPLACE
• Type of Device: FIXATION, NON-ABSORBABLE FOR PELVIC USE
• Manufacturer (Section D): FEMSELECT LTD.; hama'ayan 2; first floor; modi'in,, 71778 71; IS 7177871
• Manufacturer (Section G): RESONETICS ISRAEL LTD.; 9 ha' hadas st.; or akiva 30650 01; IS 3065001
• Manufacturer Contact: sherwyn eric ; hama'ayan 2; modi'in, 71778-71 ; IS 7177871
• MDR Report Key: 18310808
• MDR Text Key: 330283458
• Report Number: 3010892271-2023-00007
• Device Sequence Number: 1
• Product Code: PBQ
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K160569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ENPLACE
• Device Catalogue Number: FG-0001-02
• Device Lot Number: UNKNOWEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female