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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post-op to the open bowel procedure, there was intra-op no bleeding.While patient was post-op bleeding was found and resulted in a re-op.
Additional Manufacturer Narrative
(b)(4).Unknown, assumed 1st day of month that complaint was reported.Batch # unk.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.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? what surgical procedure was performed? 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? were there any issues experienced with the device in the initial surgical procedure? 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? 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? how was the post-op bleeding identified? how many days postoperative was the bleeding identified? what was the total estimated blood loss (ml)? was a transfusion required? how was the bleeding addressed? what was observed at the site during the re-operation? what was the pre and postoperative anti-coagulant and pain management protocol? was the bleeding intraluminal or extraluminal? 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: 05/09/2023.Additional information was requested, and the following was received: what were the indications for surgery? bowel resection, unknown as to why.What surgical procedure was performed? bowel resection.Did the patient receive any preoperative chemotherapy or radiation? unknown.What color reloads were used and what was the sequence of the firings? blue, 4 firings what anatomical structures was the device fired on? small bowel.Were other stapling or suturing devices used when creating the anastomosis? none that were communicated.How was the common opening closed? unknown.Were there any issues experienced with the device in the initial surgical procedure? none that were communicated.Was the device difficult to assemble/close? none that were communicated.Was the device difficult to fire; was the force to fire higher than expected? none that were communicated.How was the integrity of the anastomosis checked intraoperatively? visual inspection and no bleeding occurred at that time as was communicated.Were there any malformed staples or missing staples identified? if so, please describe the shape and location.None that were communicated.Were there any signs of tissue ischemia or necrosis? unknown.How was the post-op bleeding identified? unknown.How many days postoperative was the bleeding identified? day 1.What was the total estimated blood loss (ml)? unknown.Was a transfusion required? unknown.How was the bleeding addressed? unknown.What was observed at the site during the re-operation? unknown.What was the pre and postoperative anti-coagulant and pain management protocol? unknown.Was the bleeding intraluminal or extraluminal? unknown.What is the current status of the patient? patient released from hospital.

• 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: 16664825
• Report Number: 3005075853-2023-02170
• Device Sequence Number: 17793801
• 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): 04/03/2023

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): Follow-Up
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 05/09/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown