MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB03, 5X100 KII SH BLD ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTB03
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit will not be returning to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: lap chole event description: i was contacted by [clinical lead odp] via email on may 15, 2019: we had an incident on monday with the 100mm z-thread sleeve ref cts02 the small safety feature piece came off inside the patient, unfortunately we the team threw the sleeve away as it had been in the patient and the wrapper , we have traced it to 3 possible lot numbers 1331797, 1348167,.We only had three left on the shelf so we have pulled these and the new batch which have arrived today.Additional information received from applied medical representative via email on may 15, 2019: clinical lead odp attached a picture and marked the piece that detached.There are 3 potential lot number but someone pinched one off the desk- it's the one in the picture and threw the packaging away.The procedure was a lap chole and the surgeon was mr [].The piece in the attached photo went into the patient.Everything was retrieved from the patient.The component of the piece was clear and it was complete.As a safety precaution we have pulled the rest of the stock from shelves.Additional information received from applied medical representative via email on may 17, 2019: i have been in the account today and they have confirmed the lot number for this device was 1347100.They are still unaware of what instruments were used, but confirm it was a difficult lap chole case.I have advised the training manager of the ifu to insert all instruments axially and with the jaws closed.Type of intervention: piece fell inside the abdomen was retrieved.Patient status: no injury occurred - stable.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant's experience of seal component separation could not be replicated or confirmed.However, based on the description of the event, it is likely that the reported event was caused by non-axial insertion of removal of asymmetrical instrumentation through the trocar.Applied medical¿s instructions for use states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially through the seal to prevent tearing." this report corrects common device name from "gcj" in the initial report to "laparoscope, general & plastic surgery.".
Event or Problem Description
Procedure performed: lap chole.Event description: i was contacted by clinical lead odp via email on may 15, 2019: we had an incident on monday with the 100mm z-thread sleeve ref cts02 the small safety feature piece came off inside the patient, unfortunately we the team threw the sleeve away as it had been in the patient and the wrapper , we have traced it to 3 possible lot numbers 1331797, 1348167,.We only had three left on the shelf so we have pulled these and the new batch which have arrived today.Additional information received from applied medical representative via email on may 15, 2019: clinical lead odp attached a picture and marked the piece that detached.There are 3 potential lot number but someone pinched one off the desk- it's the one in the picture and threw the packaging away.The procedure was a lap chole and the surgeon was mr (b)(6).The piece in the attached photo went into the patient.Everything was retrieved from the patient.The component of the piece was clear and it was complete.As a safety precaution we have pulled the rest of the stock from shelves.Additional information received from applied medical representative via email on may 17, 2019: i have been in the account today and they have confirmed the lot number for this device was 1347100.They are still unaware of what instruments were used, but confirm it was a difficult lap chole case.I have advised the training manager of the ifu to insert all instruments axially and with the jaws closed.Type of intervention: piece fell inside the abdomen was retrieved.Patient status: no injury occurred - stable.

• Brand Name: CTB03, 5X100 KII SH BLD ZTHR 6/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: 8667664
• Report Number: 2027111-2019-00466
• Device Sequence Number: 19398173
• Product Code: GCJ
• UDI-Device Identifier: 00607915123512
• UDI-Public: (01)00607915123512(17)220218(30)01(10)1347100
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072674
• 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): 06/13/2019

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: 02/18/2022
• Device Model Number: CTB03
• Device Catalogue Number: 101472905
• Device Lot Number: 1347100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 06/13/2019
• Patient Sequence Number: 1