MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN); LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number ILSX

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

Patient Problem Failure to Anastomose (1028)

Event Type  Injury  

Manufacturer Narrative

Pc (b)(4).Date sent: 09/17/2020.Only event year known: 2020.Batch # unk.The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.Additional information received: additional 6 leaks were anecdotally reported by the surgeon as the rep was investigating another reported product complaint.The surgical team has a dedicated team for firing the device.These 6 cases were not the cases of dr.Jester.There surgeon could not provide additional details such as, surgeon, patient demographics or additional event details.It could not be determined what device was used in any of these procedures (cdh, ecs, or powered circ).Account is a long time ethicon account.Based on the information provided, there is no evidence that the devices used caused or contributed to the reported event.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.

Event Description

It was reported that the patient had a leak after colon surgery.Unknown as to how the procedures were completed.All available information was provided.There is no further information available now or in the future.

• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10547311
• MDR Text Key: 207366135
• Report Number: 3005075853-2020-04713
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ILSX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention