MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8302, M ALEXIS WND PROT/RET 5/BX; KGW

Model Number	C8302
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photograph of the event unit was provided by the complainant.Although the event unit was not returned, the complainant¿s experience was confirmed using the photograph that was provided.Based on the description of the event and the photograph that was provided by the complainant, it is likely that the reported event was caused by an instrument coming in contact with the sheath during the procedure.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.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.This report is combined initial and follow up report.
Event or Problem Description
Name of procedure being performed: hysteromyotomy (open), papillotomy detailed description of event: "hospital: (b)(6) hospital.Surgeon: prof.(b)(6).Department: ob/gyn.Surgery: hysteromyotomy (open).Product used: alexis (m).Date of surgery: (b)(6) 2019.Hospital called the sales manager of our distributor on (b)(6) 2019 and informed that at the end of the case, they noticed the alexis torn (bottom part-green ring side) hospital throw away the unit on friday last week and distributor can't collect the unit as they had call this morning.Question from hospital.They worried if some particles from the unit left inside of patient body.Do we have any reference or incident caused problem due to this type of incident." additional information was received via email on 15may2018 from applied med, fin and admin mgr.Cer form was received."after the procedure, alexis was teared and could not find the teared part and closed and completed the procedure.Dealers questioning to us that should be okay or not." type of intervention: "alexis was teared and could not find the teared part and closed and completed the procedure." patient status: no patient injury occurred associated with the reported event.

• Brand Name: C8302, M ALEXIS WND PROT/RET 5/BX
• Common Device Name: KGW
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8675262
• Report Number: 2027111-2019-00467
• Device Sequence Number: 11350293
• Product Code: KGW
• UDI-Device Identifier: 00607915117214
• UDI-Public: (01)00607915117214(17)210412(30)01(10)1322617
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 06/06/2019

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 Expiration Date: 04/12/2021
• Device Model Number: C8302
• Device Catalogue Number: 101355801
• Device Lot Number: 1322617
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1