MAUDE Adverse Event Report: CALDERA MEDICAL INC. TRANSVAGINAL 3.0 MM INTRODUCER; TRANSVAGINAL INTRODUCER

Catalog Number CAL-TV30

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Bowel Perforation (2668)

Event Type  Injury  

Manufacturer Narrative

Several attempts have been made to obtain additional details of the reported event and no further information has been received as of the date of this report.Awaiting instrument return for investigation.A new set of instruments were sent as replacements to the facility.Lot history records for instrument on file at the customer indicates no non-conformances or deviations that may have caused or contributed to this incident based upon the reported event.The risk of bladder/organ perforation is a known potential adverse event and is listed in the adverse reactions section of the desara tv product ifu # 10-139-06.

Event Description

On (b)(6) 2019, dr.(b)(6) reports in an email: "i was handed a trocar that had less of a curve and i punctured the bladder." surgeon and sales rep were contacted for further information.On 08/13/2019, sales rep provides additional information: "i met with her and she said the wrong trocar was brought into the or.I am going tomorrow to meet with her or nurse to look over all trocars they have and figure out which one was brought in.She said she believed the instrument handle ended in a "30".Surgeon kept trying to find the case, patient and all that info and couldn't find it and said she'd have to look into it further for me.She said she remembered the trocar instrument ending in 30 not 32 though.She unfortunately didn't have much prepared for me or much information.She said it was early this year and she had finally just got around to contacting us about it.All she could tell me: she was doing transvaginal and the trocars looked almost identical, but she noticed the handle seemed different.She thought maybe they gave her the suprapubic instrument vs transvaginal.".

Manufacturer Narrative

Two cal-tv30 instruments have been received at coroporate (lot # 46594) for investigation.Per engineering analysis both instruments of cal-tv30 passed tip inspectiont test and are considered to be within specification according to drawing 02-231 for tip dimensioning.Concluding this engineering analysis, the returned instruments demonstrate mechanical deformity due to apparent modification when measured to the device drawing and specifications.It appears that the instruments were equally modified, which affected the functionality of the instruments.Modification of instruments is contraindicated in the warnings section of the indications for use (ifu), #10-193.The disposition of these instruments is quarantined and not available for future use.

• Brand Name: TRANSVAGINAL 3.0 MM INTRODUCER
• Type of Device: TRANSVAGINAL INTRODUCER
• Manufacturer (Section D): CALDERA MEDICAL INC.; 5171 clareton drive; agoura hill CA 91301
• MDR Report Key: 8902334
• MDR Text Key: 154759328
• Report Number: 3003990090-2019-01485
• Device Sequence Number: 1
• Product Code: PWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: CAL-TV30
• Device Lot Number: 46594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Date Manufacturer Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization