MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FLUIDSMART FLUID MANAGEMENT SYSTEM; INSUFFLATOR, HYSTEROSCOPIC

Catalog Number P2000

Device Problems Improper Flow or Infusion (2954); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Unspecified Tissue Injury (4559)

Event Date 11/15/2022

Event Type  malfunction  

Event Description

It was reported that the patient's bladder was nicked during surgery.

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that the patient's bladder was nicked during surgery.

Manufacturer Narrative

Alleged failure: change in flow rate the failure identified in the investigation is inconsistent with the alleged failure.Probable root cause: not related to fluidsmart, see below: rmf 1261 rev.Ah.Line item 4.Io1 fluid suction force to high/tissue damage severity: s3 (necessitates professional medical or surgical intervention (to prevent permanent impairment) occurrence: o1 (negligible, product contained) filing rationale: based on a review of the risk documentation and the reported information regarding this event, a serious injury report will be filed for the reported serious injury.Manufacture date is not known.

Manufacturer Narrative

Updating to reference correct fda registration number - 3007495879 - endoscopy (solon).Alleged failure: change in flow rate.The failure identified in the investigation is inconsistent with the alleged failure.Probable root cause: not related to fluidsmart, see below: rmf 1261 rev.Ah.Line item 4.Io1 fluid suction force to high/tissue damage.Severity: s3 (necessitates professional medical or surgical intervention (to prevent permanent impairment).Occurrence: o1 (negligible, product contained).Filing rationale: based on a review of the risk documentation and the reported.Information regarding this event, a serious injury report will be filed for the reported serious injury.Please note, this event was initially determined as a serious injury reportable event due to patient's bladder being nicked during surgery.However, per additional information provided, the device did not cause the incident and there has been nothing that indicated that the machine caused the patient¿s bladder to get nicked.The alleged failure is due to too much suction from the neptune.Due to this, this event is now a malfunction reportable event.Manufacture date is not known.

Event Description

Please note, this event was initially determined as a serious injury reportable event due to patient's bladder being nicked during surgery.However, per additional information provided, the device did not cause the incident and there has been nothing that indicated that the machine caused the patient¿s bladder to get nicked.The alleged failure is due to too much suction from the neptune.Due to this, this event is now a malfunction reportable event.

• Brand Name: FLUIDSMART FLUID MANAGEMENT SYSTEM
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15983165
• MDR Text Key: 306924366
• Report Number: 0002936485-2022-00739
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091939
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: P2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/15/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 11/15/2022; 11/15/2022
• Supplement Dates FDA Received: 02/14/2023; 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other