MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL 5MM ROUND TIP 35CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	NSEAL535RH
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had a retained object from an unknown procedure in 2016.It was determined that the retained object was the mobile jaw from a laparoscopic device.Doctor states that she was unaware of the jaw having broken off at the time of the procedure.There were patient consequences.It is unknown if the procedure was completed successfully.
Additional Manufacturer Narrative
(b)(4).Date of event: event year only reported: 2016.Batch #: unknown.Additional information was requested and the following was obtained: what was the original procedure? laparoscopic appendectomy.What was the exact enseal product code? unsure.Probably nseal535rh.On what specific anatomical structures was the enseal device used on in the original procedure? mesoappendix.Were there any difficulties utilizing the device during the original procedure? none recorded.Was the original device used to complete the surgery? unknown, but no issues were documented in post op report.Are there any pictures or scans of the retained piece available for ethicon medical/engineer review? images are available in the patient chart.The chart would have to be requested.Was the retained product the full jaw or a piece? what does the retained piece look like? it appeared to be the mobile portion of the jaw.Did the patient present with any health-related issues that led to the identification of the retained object? the patient was involved in a car accident 4 years after the procedure and had back pain.A scout film for back pain revealed the retained object in the pelvis.How was it determined that there was a retained object in the patient? a radiograph for back pain revealed the retained object.Can the patient consequences reported be described? the patient reported pain only after the object was discovered.Are there any photos or videos available of the initial procedure? no.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ENSEAL 5MM ROUND TIP 35CM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 15794057
• Report Number: 3005075853-2022-07888
• Device Sequence Number: 4649658
• Product Code: GEI
• UDI-Device Identifier: 10705036000044
• UDI-Public: 10705036000044
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: NSEAL535RH
• Device Catalogue Number: NSEAL535RH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female