MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTS22, 12X100 KII SLEEVE ZTHR 12/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTS22
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Engineering observed that the septum, an internal rubber component of the seal, was torn and fragmented.This confirmed the complainant¿s experience of seal leakage.Based on the condition of the returned unit and description of the event, it is likely that the reported event was caused by non-axial insertion or removal of instruments (maryland grasper) through the trocar.Applied medical's instructions for use (ifu) 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 when inserted through the seal to prevent tearing." seal leakage and septum fragmentation are not considered to be reportable as they are unlikely to cause or contribute to death or serious injury.This report is to follow-up maude mw # 10683078 and medwatch # 0501290000-2020-8015.
Event or Problem Description
Procedure performed: laparoscopic roux-en-y gastric bypass with silastic ring.Event description: the port leaked through the seal.The seal housing was popped off, and was replaced with a new seal housing to complete the case.There was no component separation at the time of the leakage.The case was not robotic.A maryland grasper was being used at the time of the seal leakage.The implementation specialist was present for the case.No patient injury occurred.The device is available for return.Additional information received via maude search on 16nov2020: maude report number (b)(4).Event description: the patient was placed supine on the operating table and after the administration of general anesthesia, the abdomen was prepped and draped sterilely.Utilizing a supraumbilical incision, the skin was sharply incised, and the abdomen was cannulated with a 12-mm non-bladed trocar.Co2 insufflation was undertaken to achieve adequate pneumoperitoneum.Team noted that "trocar had air leak during surgery" (per report).Trocar was withdrawn.Another trocar was opened and inserted.Procedure continued and completed with no further incident.Manufacturer response for laparoscope, general plastic surgery, kii® sleeve (per site reporter).I have talked to the representative today, and i was given the label and return instructions.Will send the device back next week.Additional information received via mail on 18nov2020 from medwatch 0501290000-2020-8015: received patient information, and procedure performed (laparoscopic roux-en-y gastric bypass with silastic ring).Intervention: the seal housing was replaced with a new seal housing to complete the case.Patient status: no patient injury, or illness occurred associated with complaint event.

• Brand Name: CTS22, 12X100 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: 10878118
• Report Number: 2027111-2020-00628
• Device Sequence Number: 2635453
• Product Code: GCJ
• UDI-Device Identifier: 00607915123734
• UDI-Public: (01)00607915123734(17)230311(30)01(10)1383674
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2020

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: 03/11/2023
• Device Model Number: CTS22
• Device Catalogue Number: 101244801
• Device Lot Number: 1383674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 122