MAUDE Adverse Event Report: ETHICON INC. ETHICON SECURESTRAP OPEN; IMPLANTABLE STAPLE

Model Number	OPSTRAP20
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and the absorbable strap was used.It was reported that the device malfunctioned during the procedure.It was also reported that the surgeon, during the stapling, realized that two sets of staples were delivered in a single pressure.These staples were also delivered in a bad position: they were put in cross.It was reported that the surgeon tried to remove them afterwards, but some could not be removed and the surgeon is afraid that this perforates the hailstone afterwards, post-operatively immediate or delayed.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #: (b)(4).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 inc., 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.(b)(4).Device not returned.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.Additional information was requested and the following was obtained: were the straps removed or is it planned to be removed? if yes, please provide details.What is the patient¿s current status? status of product return.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 08/10/2022 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 inc., 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.Additional information was requested and the following was obtained: 1.Was the straps removed or is it planned to be removed? = > some staples could be removed and discarded.The others staples remained attached to the effective staple on the prosthesis thus fixed.There is a risk of remote gallbladder injury postoperatively.2.What is the patient¿s current status? - = >nothing to report.If further details are received at a later date a supplemental medwatch will be sent.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 08/22/2022.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 inc., 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.Component code: g07002 no device problem found.The product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the device was returned with no apparent damage in the external components.The device was disassembled to conduct a deep inspection and no damages were found on internal instrument components.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what may have caused the reported incident.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: ETHICON SECURESTRAP OPEN
• Common Device Name: IMPLANTABLE STAPLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15023427
• Report Number: 2210968-2022-05510
• Device Sequence Number: 6856094
• Product Code: GDW
• UDI-Device Identifier: 10705031231054
• UDI-Public: 10705031231054
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: OPSTRAP20
• Device Catalogue Number: OPSTRAP20
• Device Lot Number: RJMMDK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 07/22/2022; 08/16/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 08/10/2022; 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown