MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA STERISEAL SURGICAL NEEDLE

Model Number SN1320

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/05/2018

Event Type  Injury  

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 available.

Event Description

Aspen surgical received a report from the (b)(4) (ref: (b)(4)) indicating a steriseal surgical needle separated during a procedure.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

Aspen surgical received a report from the (b)(6) ((b)(4)) indicating a steriseal surgical needle separated during a procedure.The actual device was not available for evaluation.The manufacturing lot number and photographic evidence was provided for review.The report from the (b)(6) indicated that the end user experienced the superior aspect of the eye of needle (the bit through which the suture is passed) broke while suturing.The missing superior portion of the needle could not be seen or palpated in the tissues which were being sutured.The area was visually inspected and no fragments were found.The patient underwent x-ray to determine the location of the missing piece.No evidence of fragments of needle were discovered.The patient had no adverse effects.Analysis result of the finished good lot number 061580 was reviewed.No non-conformance's were noted in the dhr.The photo confirmed the condition of the broken needle.According to aspen surgical's ifu, the needles should not be clamped directly on the eye of the needle to the point and should be applied to the flat portion of the needle about 1/4 of the needle length from the eye end.However, the root cause of the break could not be currently determined through the evaluation of the photo and documentation review.Additionally, this product line was discontinued in 2016 with manufacture transfer from (b)(6) to (b)(4).Based on this information, the root cause could not be determined and no further action is required.

Event Description

Aspen surgical received a report from the (b)(6) ((b)(4)) indicating a steriseal surgical needle separated during a procedure.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: STERISEAL SURGICAL NEEDLE
• Type of Device: SURGICAL NEEDLE
• 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: 7503626
• MDR Text Key: 107892481
• Report Number: 1836161-2018-00043
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SN1320
• Device Lot Number: 061580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2015
• 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