MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CB050, 5X38CM EPIX INLINE SCISSORS 10/BX; HET

Model Number	1
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Pre-operation - scissor removed from package and upon inspection prior to case, they noticed a break in the insulation on the distal end of the scissor.Type of intervention - na.Patient status - na.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, photos of the event unit were provided by the complainant.Engineering reviewed the photos, which confirmed the complainant's experience.In the absence of the subject device, it is difficult to determine the root cause of the event.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• Brand Name: CB050, 5X38CM EPIX INLINE SCISSORS 10/BX
• Common Device Name: HET
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6639145
• Report Number: 2027111-2017-01842
• Device Sequence Number: 530822
• Product Code: HET
• UDI-Device Identifier: 00607915124519
• UDI-Public: (01)00607915124519(17)190722(30)01(10)1275440
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: 1
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2017

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
• Operator of Device: Other
• Device Expiration Date: 07/22/2019
• Device Model Number: 1
• Device Catalogue Number: 1
• Device Lot Number: 1275440
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 08/03/2017
• Patient Sequence Number: 1