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

Model Number	OPSTRAP20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Diarrhea (1811); Fever (1858); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Myocardial Infarction (1969); Pain (1994); Pleural Effusion (2010); Pneumonia (2011); Seroma (2069); Urinary Tract Infection (2120); Perforation of Vessels (2135); Hernia (2240); Impaired Healing (2378); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 inc, 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.This report is related to a clinical evaluation report (cer) from a related research activity database (drra); therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.(b)(4).Device not returned, the single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2022-09677.
Event or Problem Description
This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra) for patients undergoing unknown procedure.The reported complication as per icd 9 & 10 categorization experienced by the following with corresponding intervention: perioperative and 5-year follow-up outcomes intraoperative complications - total 37 - bleeding 18, organ injuries 27, vascular 9, bowel 14, bladder 2, stomach 0, spleen 1, liver 0, others 1.General complications - total 43 - fever 1, urinary tract infection 5, diarrhea 3, gastritis 1, thrombosis 2, pulmonary embolism 2, pleural effusion 2, pneumonia 7, copd 4, cardiac insufficiency 4, coronary hearth disease 1, myocardial infarction 1, renal insufficiency 3, hypertensive crisis 2, patient deceased 0, others 15.Postoperative complications - total 54 - bleeding 14, seroma 26, prolonged ileus or obstruction 5, bowel injury/anastomotic insufficiency 3, wound healing disorder 5, infection 4.Complication-related reoperations total 16.Recurrence, pain and complications on 5-year follow-up - recurrence 158 - pain on exertion 190, pain at rest 89, pain requiring treatment 69, trocar hernia 5, secondary hemorrhage 15, seroma 41, infection 29.

• 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: 15839420
• Report Number: 2210968-2022-09676
• Device Sequence Number: 6902259
• Product Code: GDW
• UDI-Device Identifier: 10705031231054
• UDI-Public: 10705031231054
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: OPSTRAP20
• Device Catalogue Number: OPSTRAP20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown