MAUDE Adverse Event Report: INTEGRA YORK, PA INC. MONO CABLE 10 FEET (3 METERS); PFM16

Catalog Number	600290B
Medical Device Problem Codes	Arcing (2583); Separation Problem (4043)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.Failure analysis cannot be completed due to the lack of information received to perform a complete investigation.Product has not been returned for evaluation.Lot number / serial number not received to perform dhr.The reported complaint was not confirmed.Root cause cannot be determined due to lack of information received to perform a complete investigation.
Event or Problem Description
It was reported initially that the 600290b mono cable had failed.Additional information received on 27nov2019 and 09dec2019 indicated that the incident occurred on (b)(6) 2019.It was reported that the nurses stated that the product failure was the plug in the generator, the cord separated and then arced.A 10-minute surgery delay was noted.The patient was prepped for surgery, and the device was in contact with the patient, however, there was no injury reported.

• Brand Name: MONO CABLE 10 FEET (3 METERS)
• Common Device Name: PFM16
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 10276825
• Report Number: 2523190-2019-00146
• Device Sequence Number: 13025471
• Product Code: GEI
• Combination Product (Y/N): N
• PMA/510(K) Number: K150024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2019

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: Health Professional
• Device Catalogue Number: 600290B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1