MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER STAINLESS STEEL BLADES SIZE 10, STERILE; BARD-PARKER BLADE

Model Number 371210-150

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/10/2018

Event Type  Injury  

Manufacturer Narrative

Aspen surgical received a medwatch letter from the fda (mw5078330) indicating that a bard-parker blade broke while in use during a procedure.The incident occurred at the user facility.No sample was returned and no photographic evidence was available for evaluation.A manufacturing lot number was provided for review.Bard-parker blade broke during a robotic hysterectomy with bilateral salpingectomy and cystoscopy, the blade broke at the scalpel.The broken blade piece was successfully retrieved.There were no complications to the patient and no additional treatment was required.A review of the device history record indicated no non-conformance's related to the reported issue.The most probable root cause could have been during the stamping or grinding process.Packaging process has established controls to mitigate broken or cracked blade condition, including a "medio" blade sensor that inspects 100% of packed pouches liner level prior to aluminum foil packaging.Also, excessive force applied by end user during surgery process could also cause blade condition.The following controls are in-place to mitigate "broken blade" condition at aspen surgical (b)(4) site: heat treatment in-process at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test.Heat treatment quality inspections at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test.Sample was not returned.However if sample becomes available and any additional relevant information is identified, the additional relevant information will be submitted in a supplemental report.

Event Description

Aspen surgical received a medwatch letter from the fda indicating that a bard-parker blade broke during a procedure.The incident occurred at the user facility.This report was filed in our complaint handling system as (b)(4).

• Brand Name: BARD-PARKER STAINLESS STEEL BLADES SIZE 10, STERILE
• Type of Device: BARD-PARKER BLADE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: jordan hackert ; 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6165367508
• MDR Report Key: 7776523
• MDR Text Key: 116881921
• Report Number: 1836161-2018-00088
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/17/2018

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
• Device Operator: Health Professional
• Device Model Number: 371210-150
• Device Lot Number: 0149935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention