MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ESP¿; GLOVE, PATIENT EXAMINATION, SPECIALTY

Model Number M001201131

Device Problem Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

During preparation while the physician was putting his fingers in the esp¿ gloves, a hole was noticed.A new pair of gloves was used to complete the case.

Manufacturer Narrative

Device evaluated by mfr: received one pair of size 8 gloves with its original envelope.No visible residue was found on the gloves.A visual examination of the gloves found the left glove to be without issue.The mating right glove presented a tear at the fold located in the thumb.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause is considered handling damage as the event occurred prior to patient contact.(b)(4).

Event Description

During preparation while the physician was putting his fingers in the esp¿ gloves, a hole was noticed.A new pair of gloves was used to complete the case.

• Brand Name: ESP¿
• Type of Device: GLOVE, PATIENT EXAMINATION, SPECIALTY
• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6407656
• MDR Text Key: 70063165
• Report Number: 2134265-2017-02265
• Device Sequence Number: 1
• Product Code: LZC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K891968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M001201131
• Device Catalogue Number: 20-113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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