MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) HYDRATOME¿ RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00583040

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the device lot number. Therefore, the manufacture and expiration dates are unknown. (b)(6). Although the suspect device has been received, the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined. Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a hydratome¿ rx 44 was unpacked. According to the complainant, during unpacking, it was noted that there was a hair inside the sealed packaging of the device. There was no procedure involved and the device was not used in the patient.

Manufacturer Narrative

Visual examination of the returned device on its original sealed pouch revealed that there was a hair found in the pouch on the sealed section. No other anomalies or damages were encountered. The complaint was consistent with the reported event of foreign matter inside the package. Based on the investigation and the receipt condition/functionality, the complaint conclusion investigation code selected for this complaint is "manufacturing execution error", since the manufacturing process was not executed as validated/as designed, once during the visual inspection a hair was found in the pouch on the seal section. An investigation has been initiated to address this issue. A dhr (device history record) review was performed and no deviation was found.

Event Description

It was reported to boston scientific corporation that a hydratome¿ rx 44 was unpacked. According to the complainant, during unpacking, it was noted that there was a hair inside the sealed packaging of the device. There was no procedure involved and the device was not used in the patient.

• Brand Name: HYDRATOME¿ RX 44
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7394581
• MDR Text Key: 104425837
• Report Number: 3005099803-2018-00960
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/29/2021
• Device Model Number: M00583040
• Device Catalogue Number: 8304
• Device Lot Number: 21676539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage