MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CARB-EDGE IRIS SCS 4-1/2 STR; N/A

Model Number 101300

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the carb-edge iris scissors (101300) was broken during use by the action of a small force.It was initially reported that the device was not in contact with the patient at the time it broke and was discovered broken after surgery.However, subsequent information was received reporting that the fracture occurred during the clamping in surgery.Reportedly, it took a while for staff to find a broken piece of instrument in the surgical site and a replacement instrument not already on the surgical set took time to prepare.An unspecified delay in surgery time occurred and the surgeon had to repeat the surgical procedure.To note, the apparatus was cleaned and disinfected according to prescribed protocol.The facility checked the cleaning, sterilization and management of the instrument, but no problems were found in the process.

Event Description

N/a.

Manufacturer Narrative

The suspected carb-edge iris scissors (101300) was not returned for evaluation, after three good faith efforts (gfe) to obtain the product.Lot number was provided, device history record (dhr) was reviewed and no abnormalities related to the reported issue were identified.The product lot number indicates a manufacture date of 2019.The issue of breaking during use may be the result of wear or environmental damage over time.However, a definitive root cause could not be determined.

Manufacturer Narrative

The carb-edge iris scissors (101300) was subsequently returned for evaluation: the carb-edge iris scissors was received in used condition with one of the tips broken off of due to rough handling/environmental damage.The product lot number indicates a manufacture date of 2019 and the sales order was sold in 2020, indicating damage may have occurred due to wear over two years of use.The reported complaint was confirmed.No manufacturing, workmanship or material deficiency has been identified.

• Brand Name: CARB-EDGE IRIS SCS 4-1/2 STR
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15933117
• MDR Text Key: 307790532
• Report Number: 3014334038-2022-00273
• Device Sequence Number: 1
• Product Code: HNF
• UDI-Device Identifier: 10381780375029
• UDI-Public: 10381780375029
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101300
• Device Catalogue Number: 101300
• Device Lot Number: AA1903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2019
• 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