MAUDE Adverse Event Report: BLACK & BLACK SURGICAL, INC. TEBBETTS FIBEROPTIC RETRACTOR

Model Number B61088

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

After evaluation of device, it was determined that the retractor had been damaged by the user.When looking at the fiber surface under magnification, several impact marks and lines can be seen, which suggests that some sort of impact took place.The metal surrounding the fiberoptics has mushroomed slightly.Once damaged, the heat was no longer able to dissipate as designed and the temperature would have risen at the location of the damage.This increased temperature then caused the fiber surface to burn, thus leading to a more substantial failure: in this case, a piece of fiberoptic bundle came off.Based on this evaluation, it can be determined that the failure could not have happened while in contact with the patient, rather possibly during reprocessing or at the time of impact.

Event Description

Regarding the fiberoptic retractor, the customer stated that there was "deterioration / breakage of fibres at the distal end of instrument" and because it was unknown if device was in contact with patient during failure, the event is being reported.

• Brand Name: TEBBETTS FIBEROPTIC RETRACTOR
• Type of Device: FIBEROPTIC RETRACTOR
• Manufacturer (Section D): BLACK & BLACK SURGICAL, INC.; 5175 s royal atlanta dr; tucker GA 30084
• Manufacturer Contact: cynthia rees ; 5175 s royal atlanta drive; tucker, GA 30084 ; 7704144880
• MDR Report Key: 8303203
• MDR Text Key: 136616457
• Report Number: 3006142527-2019-00001
• Device Sequence Number: 1
• Product Code: FDG
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B61088
• Device Catalogue Number: B61088
• Device Lot Number: K15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other