MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA SCALPEL HOLDER RED, ASPEN LEAF WITH BARD-PARKER, STERILE

Model Number ST-100

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

No further information is available on the product at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.Device not returned.

Event Description

Aspen surgical received a report from the distributor indicating that the seal of a scalpel holder pouch was not intact.The item was not in use and no injury/death was reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

Aspen surgical received a report from the distributor indicating that the seal of a scalpel holder pouch was not intact.The item was not in use and no injury/death was reported.No sample was available for evaluation.Photographic evidence along with manufacturing lot number was provided for review.Analysis of the finished good lot number 144975 was reviewed.No non-conformance's were noted during the manufacturing process.A review of the photo confirmed that the opened seal was present on the product.Manufacturing engineering was consulted.The film roll stock is affixed to a plastic core by a strong adhesive that does not release when the roll is depleted.There are sensors on the machine that will alert the operator when the material gets low and a sensor for when the material runs out.When the sensor detects that the material is out, it will stop the machine.However, if an operator is not properly trained, he/she can start the machine back up.This allows the machine to continue to run with this material held back by the plastic roll.As the material is held back, an extreme force is applied to the packages located near the sealing area.This force causes the improper sealing of the package.Therefore, the root causes contributing to the event was due to a manufacturing issue and operating error.Additionally, the pouch label identifies this failure mode with the symbol "do not use if package is damaged".This indicates that the device should not be used if the products sterile barrier system or its packaging is compromised.Based on this information, no further action is required.Device not returned.

Event Description

Aspen surgical received a report from the distributor indicating that the seal of a scalpel holder pouch was not intact.The item was not in use and no injury/death was reported.This report was filed in our complaint handling system as (b)(4).

• Brand Name: SCALPEL HOLDER RED, ASPEN LEAF WITH BARD-PARKER, STERILE
• Type of Device: SCALPEL HOLDER
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• MDR Report Key: 7365224
• MDR Text Key: 103554142
• Report Number: 1836161-2018-00031
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ST-100
• Device Lot Number: 144975
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1