MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG; HEATED TUBESET WITH RTP FOR PNEUMO SURE (10-PK); INSUFFLATOR, LAPAROSCOPIC

Catalog Number	0620040690
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: the tube set became detached from the cassette.Probable root cause: use error unwanted movement of internal components/wiring tubeset/gas supply inadvertently detached/loose leaks from internal connections or seals manufacturing/service error.The failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.
Event or Problem Description
It was reported that the tubing became detached, which could potentially lead to a loss of insufflation.

• Brand Name: PKG; HEATED TUBESET WITH RTP FOR PNEUMO SURE (10-PK)
• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8932398
• Report Number: 0002936485-2019-00357
• Device Sequence Number: 16250910
• Product Code: HIF
• UDI-Device Identifier: 37613327055659
• UDI-Public: 37613327055659
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K003792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/26/2019

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 Catalogue Number: 0620040690
• Device Lot Number: 18K0374
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 129