MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*55MM LINEAR CUTTER; STAPLE, IMPLANTABLE

Model Number	TLC55
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	03/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported there was a staple line leak.Staple line leak.No further information available at this time.Procedure: bladder surgery.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/21/2023.B3: only event year known: 2023.D4: batch # unk.Attempts have been made to retrieve the device.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.The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.Additional information was requested, and the following was received: was there any other issue noted with the staple line other than leak (malformed staples, staple line missing staples, etc.)? there were no issues or concern with the staple line after firing the device.How was the leak controlled? ir drains, adjusted nutrition to hyperalimentation for bowel rest.Did the patient require a transfusion? no.Was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.) yes, patient had a leak which required a longer length hospital stay.Had to move to hyperalimentation to stop the leak.Please provide the source or name of person providing answers to follow-up questions (not the person relaying/submitting answers to loc or chu).Dr.(b)(6).(resident).Operation date: (b)(6) 2023.Leak identified 9 days later.Procedure: bladder augmentation, appendicovesicostomy, bladder neck transection.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.What were the indications for surgery? did the patient receive any preoperative chemotherapy or radiation? what color reloads were used and what was the sequence of the firings? what anatomical structures was the device fired on? were other stapling or suturing devices used when creating the anastomosis? how was the common opening closed? was the device difficult to assemble/close? was the device difficult to fire; was the force to fire higher than expected? how was the integrity of the anastomosis checked intraoperatively? how was the leak identified? was it leaking through the staple line? were there any malformed staples or missing staples identified? if so, please describe the shape and location.Were there any signs of tissue ischemia or necrosis? what is the current status of the patient? 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 field as appropriate.
Additional Manufacturer Narrative
(b)(4).Date sent: 05/16/2023.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.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.Additional information was requested, and the following was received: what were the indications for surgery? bladder exstrophy did the patient receive any preoperative chemotherapy or radiation? no what color reloads were used and what was the sequence of the firings? blue 55mm tlc x2 what anatomical structures was the device fired on? sigmoid colon were other stapling or suturing devices used when creating the anastomosis? no how was the common opening closed? blue 60mm tx was the device difficult to assemble/close? no to either the tlc or tx was the device difficult to fire; was the force to fire higher than expected? no to either the tlc or tx firings how was the integrity of the anastomosis checked intraoperatively? palpations how was the leak identified? ct scan & drainage in drain was it leaking through the staple line? "probably" were there any malformed staples or missing staples identified? if so, please describe the shape and location.No were there any signs of tissue ischemia or necrosis? no.What is the current status of the patient? no more leak and patient has been discharged.

• Common Device Name: 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16789261
• Report Number: 3005075853-2023-02786
• Device Sequence Number: 5435795
• Product Code: GDW
• UDI-Device Identifier: 10705036013204
• UDI-Public: 10705036013204
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K020779
• 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,Followup
• Report Date (Section B): 04/21/2023

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
• Operator of Device: Health Professional
• Device Model Number: TLC55
• Device Catalogue Number: TLC55
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 05/16/2023
• 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: TCR55 (LOT # UNKNOWN)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown