MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTS02, 5X100 KII SLEEVE ZTHR 12/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTS02
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.This report is to follow-up medwatch # (b)(4).
Event or Problem Description
Procedure performed: laparoscopic peritoneal dialysis.Event description: received via mail, medwatch uf/importer report # (b)(4)."while inserting the trocar, it bent." additional information received via email on 28aug2020 from user facility: the location of the bend was on the mid shaft of trocar.The obturator was inside the cannula at the time of the incident.It is unknown if there was difficulty with the insertion.The whole product was replaced.It is unknown how the case was completed after the event occurred.The unit is available for return.Additional information received via phone on 17sep2020 from account manager: the facility is returning a obturator from a ctf03 of lot 1384278 and a cannula from a cts02 of lot 1383546.They were both used in the same case.The rep was not able to confirm if the products were used together in the case.Intervention: the whole product was replaced.Patient status: no adverse event reported.Reported only as product problem.
Event or Problem Description
The event unit contained components from two different models: component 1 of 2 (2027111 - 2020 - 00546), component 2 of 2 (2027111 - 2020 - 00565).Event description: received via mail, medwatch uf/importer report # (b)(4)."while inserting the trocar, it bent." event occurred in july 2020.Additional information received via phone on 27aug2020 from user facility: the event date is 15jul2020.Additional information received via email on 28aug2020 from user facility: the location of the bend was on the mid shaft of trocar.The obturator was inside the cannula at the time of the incident.It is unknown if there was difficulty with the insertion.The whole product was replaced.It is unknown how the case was completed after the event occurred.The unit is available for return.Additional information received via phone on 17sep2020 from applied medical account manager i: the facility is returning a obturator from a ctf03 of lot 1384278 and a cannula from a cts02 of lot 1383546.They were both used in the same case.The rep was not able to confirm if the products were used together in the case.Intervention: the whole product was replaced.Patient status: no adverse event reported.Reported only as product problem.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a bent cannula.The wall thickness of the cannula shaft was measured and met specifications.Based on the condition of the returned unit and the description of the event, it is likely that the cannula bent due to a high insertion force that was applied to the unit during insertion.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.A bent cannula is not considered to be reportable as it is unlikely to cause or contribute to death or serious injury.This report is to follow-up medwatch #: (b)(4).

• Brand Name: CTS02, 5X100 KII SLEEVE ZTHR 12/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10583794
• Report Number: 2027111-2020-00565
• Device Sequence Number: 19613906
• Product Code: GCJ
• UDI-Device Identifier: 00607915123499
• UDI-Public: (01)00607915123499(17)230317(30)01(10)1383546
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020

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: 03/17/2023
• Device Model Number: CTS02
• Device Catalogue Number: 101208701
• Device Lot Number: 1383546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CTF03 OBTURATOR
• Patient Age: 40 YR
• Patient Weight: 28