MAUDE Adverse Event Report: APPLIED MEDICAL B7086, FORTE AXP SHTH 12/14/18 55CM; FED

Model Number	B7086
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device anticipated to return.A follow-up report will be provided upon completion of investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.
Event or Problem Description
Ureterorenoscopy- "distal end of the sheath broke off and was found in the renal calix.The piece which was broken off, had to be retrieved with a stone retrieval basket." distales ende der schleuse ist abgebrochen und lag im nierenkelch.(clean break).Type of intervention - "the piece which was broken off, had to be retrieved with a stone retrieval basket." patient status - ok.
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering noted that the tip of the sheath was detached; the tip was not returned for evaluation.Engineering was able to visually confirm the event described as the distal end of the sheath was broken.Although the root cause of this incident could not be determined, this type of event could possibly occur if the tip is not properly formed and stress is placed on the device or if there is rough interaction with an instrument.As this is the first complaint of this type that we have received, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.Additional information was requested and received.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then the supplemental report will be submitted to the fda.

• Brand Name: B7086, FORTE AXP SHTH 12/14/18 55CM
• Common Device Name: FED
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5536721
• Report Number: 2027111-2016-00257
• Device Sequence Number: 725759
• Product Code: FED
• UDI-Device Identifier: 00607915113209
• UDI-Public: (01)00607915113209(17)171203(30)01(10)1236349
• Combination Product (Y/N): N
• PMA/510(K) Number: K993650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/03/2017
• Device Model Number: B7086
• Device Catalogue Number: 100794904
• Device Lot Number: 1236349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2016
• Supplement Report FDA Received Date: 09/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Other; Required Intervention