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Model Number 470298-11
Device Problem Device Issue (2379)
Patient Problem Blood Loss (2597)
Event Date 03/01/2018
Event Type  Injury  
Manufacturer Narrative
The stapler 45 instrument and reloads have not been returned for evaluation. Therefore, the root cause of the patient¿s post-operative complication cannot be determined. A follow-up mdr will be submitted if the instrument or reloads are returned (post failure analysis evaluation) or if additional information is received. Isi has reviewed the site¿s system logs with a procedure date (b)(6) 2018. No related system errors were found to have occurred during the surgical procedure. The logs reveal that two green stapler 45 reloads were fired. Both firings completed. There were no incomplete clamps. Based on the information provided, this complaint is being reported due to the following conclusion: after undergoing a da vinci-assisted surgical procedure, the patient experienced a staple line bleed on post-operative day #1. The patient required reoperation that same day. However, at this time, the root cause of the post-operative complication is unknown.
Event Description
It was initially reported that after undergoing a da vinci-assisted left resection and splenectomy procedure, the patient experienced bleeding on the staple line. More specifically, bleeding was observed from the pancreatic remnant. As a result, the patient underwent another operation and the following surgical procedures were performed: suturing of the pancreatic remnant, bruise removal, and insertion of an irrigation drain. A principle investigator from the site commented, "the bleeding was from the staple line of the pancreas on the first post-operative day. This is possibly device-related although of course we are not able to say whether the bleeding would not have happened with a conventional stapler. " on 26-mar-2018, intuitive surgical, inc. (isi) contacted the site and obtained the following additional information regarding the reported event: the surgical procedure was not recorded on video. The surgical staff did not encounter any errors while the stapler 45 instrument was in use. There were no reports of any clamping, firing, or unclamping issues with the stapler 45 instrument. In addition, there were no malformed staples and the surgeon did not encounter any obstructions such as clips, staples, or other hard material while firing two green stapler 45 reloads during the procedure. According to the site, the bleeding was at the top end of the staple line and a surgical assistant had actually placed 2 metal clips during the surgery. The site admitted that the target tissue was "thick" and there was "some tissue tension" when the green stapler 45 reloads were fired. According to the stapler 45 instrument user manual, the following is noted: "warning: overly thick or thin tissue may result in unacceptable staple formation. Always consider the combined thickness of tissue and any staple line reinforcement material in use when choosing the proper reload. " the estimated blood loss from the staple line bleed was approximately 200 ml. The reoperation was performed on post-operative day #1.
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Type of DeviceSTAPLER 45
Manufacturer (Section D)
950 kifer rd.
Manufacturer (Section G)
950 kifer road
sunnyvale CA 94086
Manufacturer Contact
tabitha reed
950 kifer road
sunnyvale, CA 94086
MDR Report Key7397656
MDR Text Key104405336
Report Number2955842-2018-10112
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Patient
Type of Report Initial
Report Date 03/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number470298-11
Device Lot NumberS11170801 0005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 04/04/2018 Patient Sequence Number: 1