MAUDE Adverse Event Report: ETHICON INC. ENDOLOOP LIGATURE UNKNOWN PRODUCT; LAPROSCOPE, GENERAL & PLASTIC SURGERY

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

Patient Problem Not Applicable (3189)

Event Date 09/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: this surgeon did not perform the original procedure.The original procedure was performed by another surgeon at another facility out of town.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.The patient demographic info: weight, bmi at the time of index procedure what was the date of the initial appendectomy procedure? what were the findings from the appendectomy? were any unusual findings discovered? can you identify the product code of the endoloop suture used in initial procedure? what tissue was the suture used on during the initial procedure? what were the patient symptoms on (b)(6)? can you describe the appearance of the suture during the second procedure? were any photos taken of suture remnants? where were the remnants were found? do you have any results of pathology performed on remnants? what was the indication for the exploratory laparotomy procedure? what is physician¿s opinion as to the etiology of or contributing factors to this event? what was the indication for the bowel resection? what part of bowel was resected? was there a pathology report for the bowel? what is the patient¿s current status?.

Event Description

It was reported that the pediatric patient underwent appendectomy on an unknown date and suture was used.Thirty three days post-op, the patient presented to the facility and an exploratory laparotomy was performed.The surgeon believed the suture was no longer in position and removed what was believed to be remnants of a suture and sent it to pathology for analysis.The patient ended up having a bowel resection.The facility and surgeon of the original procedure are unknown.Additional information has been requested.

• Brand Name: ENDOLOOP LIGATURE UNKNOWN PRODUCT
• Type of Device: LAPROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9187127
• MDR Text Key: 166958480
• Report Number: 2210968-2019-88623
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR