MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOTOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00545170

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an autotome rx 44 was unpacked on (b)(6), 2021.When the physician unpacked the package of the device, it was found that the packaging was not tightly sealed and was contaminated.It was reported that the sterile barrier was compromised.There was no procedure involved and the device was not used in the patient.

Manufacturer Narrative

Block h6 (device codes): medical device problem code a020503 captures the reportable event of unsealed device packaging, compromising the sterile barrier.Block h10: the returned autotome rx 44 was analyzed, and a visual evaluation noted that the device does not show any damage.This device was not used as reported due to a packaging problem.The device packaging was not returned for analysis.No problems with the device were noted.The reported complaint packaging seal compromised could not be confirmed.Upon analysis, it was found that the device does not show any damage and the device packaging was not returned for analysis.It is likely that the reported problem occurred during transport since the records of the production of the batch detected no problems in the finished product process.Based on all gathered information, the most probable root cause of this complaint is cause not established.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaints exist for the specified lot.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that an autotome rx 44 was unpacked on (b)(6) 2021.When the physician unpacked the package of the device, it was found that the packaging was not tightly sealed and was contaminated.It was reported that the sterile barrier was compromised.There was no procedure involved and the device was not used in the patient.

• Brand Name: AUTOTOME RX 44
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12274661
• MDR Text Key: 264976342
• Report Number: 3005099803-2021-03844
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729444749
• UDI-Public: 08714729444749
• Combination Product (y/n): N
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/24/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2023
• Device Model Number: M00545170
• Device Catalogue Number: 4517
• Device Lot Number: 0025858717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 08/04/2021
• Supplement Dates Manufacturer Received: 08/06/2021
• Supplement Dates FDA Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1