MAUDE Adverse Event Report: INTEGRA YORK, PA INC. LED HEADLIGHT ONLY; LIGHTING

Catalog Number 90500

Device Problems Smoking (1585); Sparking (2595)

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

Event Date 01/19/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Between 05nov2019 and 30jun2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via (b)(6), integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between (b)(6) and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the (b)(6) application to a new data center during the transition of integra's corporate headquarters from (b)(4) to (b)(4).Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa (b)(4) and nc (b)(4) have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period 05nov2019 through 30jun2020.Integra lifesciences contacted (b)(4), director of regulatory programs, office of product evaluation and quality and (b)(4), assistant director, mdr team, office of product evaluation and quality on (b)(6) 2020 to report these issues regarding mdr reports.

Event Description

A medwatch form with uf/importer report # (b)(4) was received on 31jan2020 with the following information: on (b)(6) 2020, an operating room patient care technician was setting up an operating room for a surgery that required the use of a headlight.The 90500 led headlight only was used along with a battery pack that clips to the surgeon's waist.The patient care technician correctly identified the headlight and grabbed a cord believed to be the connector between the headlight and battery pack, as it looked the same.He brought the two components together and stated that there was a spark, smoke, and this caused him to drop the two components.The cord belonged to a wall unit battery charger for another piece of equipment, a competitor¿s product.Additional information was received on 03feb2020 indicating that the event occurred prior to the procedure.The room was being prepared for use and the headlamp was being attached to what was thought to be the correct battery pack.The event occurred in a storeroom of sorts and not the or room with oxygen.The event involved an employee.

Manufacturer Narrative

Additional information: d10, g4, g7, h2, h3, h4, h6, h10 device identifier: 103178019684825 the device was returned for evaluation.Upon evaluating this unit, there was no power to the control board, the module assembly was cracked in the right corner, and the rear cover was missing pieces.No other issues were found with this unit.The reported complaint was confirmed due to the lack of power to the control board.No manufacturing, workmanship, or material deficiency has been identified.Between(b)(6)2019 and (b)(6)2020 , approximately (b)(4) mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr 229048 and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period (b)(6)2019 through (b)(6)2020.Integra lifesciences contacted donna engleman, director of regulatory programs, office of product evaluation and quality and michelle rios, assistant director, mdr team, office of product evaluation and quality on (b)(6) 2020 to report these issues regarding mdr reports.

Event Description

N/a.

• Brand Name: LED HEADLIGHT ONLY
• Type of Device: LIGHTING
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 10277942
• MDR Text Key: 198940853
• Report Number: 2523190-2020-00015
• Device Sequence Number: 1
• Product Code: FSR
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 90500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Initial Date Manufacturer Received: 01/31/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 03/03/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPIDER 2 CORD; SPIDER 2 CORD
• Patient Age: 61 YR